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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured

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(+)-METHYL-(2-CHLOROPHENYL)-(2-THIOPHEN-2YL-ETHYLAMINO) ACETATE HYDROCHLORIDE

(2R, 3S)-2[(1R)-1-[3,5-BIS(TRIFLUOROMETHYL)PHENYL]ETHOXY]-3-(4-FLUOROPHENYL)-MORPHOLINE, 4-METHYLBENZENESULFONATE

(6,7)-3-hydroxymethyl-7-(z-2-methoxyimino-2-(fur-2-yl)acetamido)ceph-3-em-4-carb (640/2 sodium)

(R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR (R)-MPD

1,2-dihydrotriamcinolone

1,3 PROPANEDIOL 2 PHENYL

1-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-METHYLPIPERAZINE (M3 INTERMEDIATE FOR MIRTAZAPINE)

2,4-THIAZOLE WING ACID HOSU A ESTER

2,4-dichlorobenzyl alcohol

2-AMINO-3,8-DIMETHYLIMIDAZOL[4,5-F]QUINOXALINE-2-14C

2-CHLORO-2',3'-O-ISOPROPYLIDENEADENOSINE-5'-N-ETHYLCARBOXAMIDE

3-oxo-4-azaandrost-5-ene-17beta-carboxylic acid Delta-5-4-Aza-Acid

3990 ACID, PHARMACEUTICAL INTERMEDIATE

4-METHOXY-2,3,6-TRIMETHYLBENZALDEHYDE

5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID

6,7- DIMETHOXY- 3,4- DIHYDROISOQUINOLINE HYDROCHLORIDE

6,7-DIFLUOROACID FORM INTERMEDIATE

A-87172.0

A88820.605

ABIRATERONE ACETATE

ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE

ACETYLTRI-N-BUTYL CITRATE

ACETYLTRI-N-HEXYL CITRATE (ATHC)

ACETYLTRIETHYL CITRATE

ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)

AMLODIPINE BESYLATE MONOHYDRATE

ANASTROLZOLE

APREPITANT

APREPITANT (DRUG SUBSTANCE, NON-STERILE)

ARIPIPRAZOLE

ARSENIC TRIOXIDE

ATAZANAVIR SULFATE

ATORVASTATIN ATV44 (L1)

ATORVASTATIN CALCIUM, NON-STERILE BULK DRUG SUBSTANCES

ATORVASTATIN SODIUM NON-STERILE BULK DRUG SUBSTANCE

Acetylcysteine

Aciclovir

Alanine

Albendazole

Allopurinol

Alphamethyl Epoxide

Alprazolam

Aluminium oxide, hydrated 0325

Amisulpride

Amoxicillin sodium Sterile, Process Y

Amoxicillin trihydrate Powder, compacted and micronised powder

Anorganic Bone Mineral

Aprotinin concentrated solution Activity: 100 - 136 Ph. Eur. Units of aprotinin activity per mL Bacterial endotoxin free

Arginine hydrochloride

Aripiprazole

Ascorbic acid

BEPOTASTINE BESILATE

BERAPROST SODIUM

BIOPRO

BORTEZOMIB

BPS-314d DRUG SUBSTANCE

BRINZOLAMIDE USP

BULK PRODUCTION OF OXENDOLONE IN THE HIKARI PLANT

Betadex

Betahistine dihydrochloride

Betahistine mesilate

Betamethasone Triene (Betamethasone 6/6 BMS)

Betamethasone valerate

Betamethyl Epoxide, 11 DB (17a,21-dihydroxy-16b-methyl-9b,11b-oxidopregna-1,4-diene-3,20-dione)

Bitek Fermentation Broth Product code 214947

Blood Agar Base, Columbia Product codes: 279220, 279230 and 279240

Bordet Gengou Agar Base (Product codes: 211050 and 211051)

Bovine Calf Serum

Bovine Calf Serum (Product codes: 15-180 and 15-182)

Bovine Hemin Sigma-Aldrich Product number H5533, Sioux Biochemical product number 0755

Bovine Lipoprotein (Catalogue number 4505)

Bovine Plasma New Zealand origin

Bovine Transferrin Apo, iron-free; Holo, iron-saturated

Brain Heart Infusion (codes 237200, 237300, 237400, 237500, 241810, 241820, 241830, 249910 and 250220

CAFFEINE (ANHYDROUS)

CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL USP

CARBIDOPA (NON-STERILE, BULK FORM)

CARBOPLATIN

CARVEDILOL PHOSPHATE

CEFSULODIN SODIUM (SCE-129)

CELECOXIB

CELECOXIB, USP

CETIRIZINE HYDROCHLORIDE USP

CETYLPYRIDINIUM CHLORIDE USP

CHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

CHOLECALCIFEROL

CHROMIUM (III) PICOLINATE

CIMETIDINE

CINACALCET HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE

CISPLATIN

CLOPIDOGREL BISULFATE

COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP

CRUDE HEPARIN SODIUM

CS-526 DRUG SUBSTANCE

CS-615 DRUG SUBSTANCE

CS-747 DRUG SUBSTANCE

Caffeine

Calcitonin (salmon) Sterile - Synthetic Origin

Calcium carbonate

Calf Serum

Carbidopa

Carbocisteine

Carboplatin

Cefazolin sodium sterile, process B

Cefradine

Ceftriaxone sodium Sterile

Cefuroxime axetil amorphous

Chocolate Agar Plates

Cholic acid

Chondroitin sulfate sodium terrestrial avian origin

Cisapride monohydrate

Cisplatin

Clopidogrel hydrogen sulfate

Collagen

Collagen Semed F

Cortisone acetate

Cyproterone acetate

Cysteine Hydrochloride Monohydrate

D-THREO-RITALINIC ACID

DAPTOMYCIN

DEFERASIROX

DEXLANSOPRAZOLE

DORZOLAMIDE HYDROCHLORIDE

DS-1442B DRUG SUBSTANCE

DULOXETINE HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

Dacarbazine

Defibrinated calf blood

Deoxyribonuclease I

Dexamethasone

Dextromethorphan hydrobromide

Diclofenac sodium

Dicloxacillin sodium sterile

Diflorasone Diacetate

Dihydroergotamine mesilate

Diketo Acid

Diosmin Process II, non-micronised and micronised powder

Docetaxel

Domperidone maleate

Donor Bovine Calf Serum Product code 15-147

Doxycycline hyclate

Doxycycline monohydrate

Dry Bovine Collagen Fibre

ELASTOSIL(R) LR 3003/20 A/B - RAL 6010

ELASTOSIL(R) LR 3003/30 A/B - RAL 6010

ELASTOSIL(R) LR 3003/70 A/B - RAL 6010

ELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE)

EM574

ENOXAPARIN SODIUM USP

EPTIFIBATIDE

ESOMEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE)

ESTAZOLAM (TA-8)

ETHYL L-CYCLOPROPY-6,7-DIFLUORO-1,4-DIHYDRO-8-METHOXY-4-OXO-3-QUINOLINECARBOXYLATE(6,7-DIFLUOROESTER FORM) DRUG SUBSTANCE

ETODOLAC

EVEROLIMUS

EZETIMIBE

Estradiol Cypionate

Estramustine Phosphate

Exemestane

FACILITIES AND OPERATING PROCEDURES IN HIKARI-CITY, YAMAGUCHI, JAPAN

FACILITIES FOR THE G. OF BERAPROST SODIUM IN NAGOYA, JAPAN

FEBUXOSTAT

FELBAMATE

FELODIPINE

FENOFIBRATE USP

FERRIC CITRATE

FOLIC ACID

Flucloxacillin sodium

Fludrocortisone acetate

Flumethasone

Flumethasone 6

Foetal Bovine Serum

Foetal Bovine Serum (Product code 14-502)

Foetal Bovine Serum Gamma-irradiated and non gamma-irradiated (Product codes: S 0410, S 0413, S 0415, S 4110, S 4113 and S 4115)

Foetal Calf Serum

Fresh bilberry fruit dry extract, refined and standardised DER: 153-76:1

GABAPENTIN USP

GEFITINIB

GEIBROZIL USP

GLIMEPIRIDE

Gelatin Acid bone Gelatin, including NaOH treatment

Gelatin Acid bone gelatin American origin (American origin)

Gelatin Alkaline-Processed Chromium-Tanned Hide Gelatin-Spa Alkaline-Processed Hide Gela

Gelatin Limed hide gelatin

Gelatin US Enzymatic Bone Gelatin Hydrolysate

Gliclazide

Glucose monohydrate

Growth Enhancement Media Supplement product code 81-129, 81-150

HALOBETASOL PROPIONATE

HYDROCORTISONE ACETATE USP BULK API

HYDROCORTISONE BASE

HYDROCORTISONE BASE USP BULK API

HYDROCORTISONE VALERATE USP

HYDROMORPHONE HYDROCHLORIDE

HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG

Haloperidol

Heptaminol hydrochloride

Hydrocortisone acetate

Hydrocortisone hydrogen succinate /sodium succinate (or Hydrocortisone hemisuccinate / sodium succinate)

Hydroxy Acid 6a,9a-Difluoro-11b,17a-dihydroxy-16a-methyl-3-oxoandrosta-1,4diene-17b-carboxyli

IDEBENONE (NON-STERILE)

INTERMEDIATE FOR MONTANIDE ISA 50

IRBESARTAN

IRBESARTAN USP

IRON (III) HYDROXIDE POLYMALTOSE COMPLEX

Indapamide Standard and micronised

Isoniazid

Isosorbide mononitrate, diluted

Itraconazole

KETOSULFONE

Ketoconazole

L-Ala-pAF-OH HCl

L-METHIONINE SULFOXIMINE

LAMOTRIGINE

LANSOPRAZOLE

LANSOPRAZOLE USP

LANSOPRAZOLE, NON-STERILE DRUG SUBSTANCE

LEUPROLIDE ACETATE

LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVODOPA

LEVOFLOXACIN HEMIHYDRATE

LEVONORGESTREL USP 23

LINAGLIPTIN

LINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE

LOSARTAN POTASSIUM

LULICONAZOLE

LUPRON DEPOT AND LUPRON DEPOT VEHICLE

Labetalol Hydrochloride

Lactulose, liquid 667g/l

Lactulose, liquid 670g/l, 695g/l, 720g/l

Levothyroxine sodium Product code 083508 and product code 083510

Lidocaine hydrochloride monohydrate

Loperamide hydrochloride

Loperamide oxide monohydrate

Lovastatin

MANUF OF CEFMENOXIME HCL IN THE HIKARI PLANT

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN SHIZUOKA PREFECTURE, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERTATING PROCEDURES IN SHIZUOKA, JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ISHIKAWA, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN IWATA, JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHONAN PLANT.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ZIEFEN, SWITZERLAND.

MANUFACTURING SITE, FACILTIES, PERSONNEL AND OPERATIONAL PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN

MECLIZINE HYDROCHLORIDE USP

METFORMIN DC 92.6% LUBRICATED GRANULES

METFORMIN HYDROCHLORIDE

METHACYCLINE

METHOHEXITAL, NON-STERILE, BULK DRUG

METHOXYPOLY (ETHYLENE GLYCOL) PROPIONALDEHYDE

METHOXYPOLY (ETHYLENE GLYCOL) SUCCINIMIDYL CARBONATE 5K

METHYLDOPA (NON-STERILE, BULK FORM)

METOPROLOL SUCCINATE USP

METOPROLOL TARTRATE USP

METRONIDAZOLE

MILNACIPRAN

MONOALDEHYDE (3-[2-(7-CHLORO-QUINOLIN-2-YL)-VINYL]-BENZALDEHYDE)

MONTANIDE ISA 206

MONTANIDE ISA 25

MONTANIDE ISA 720

MONTANIDE ISA 740

MONTANOX 80 LPI

MONTANOX 80DF

MONTELUKAST BACKONE DIOL

MYCOPHENOLATE MOFETIL

Magnesium citrate

Meat peptones Product codes: 102, 130, 144, 147 and 310

Medroxyprogesterone acetate

Meropenem trihydrate Sterile and synthetic origin

Mesalazine

Methadone hydrochloride

Methoxy-C15-WITTIG Salt (TGN05), Intermediate for Acitretin API

Methylprednisolone hydrogen succinate (or Methylprednisolone hemisuccinate)

Metoprolol tartrate

Miconazole nitrate

MicroCrystalline Hydroxyapatite Compound

Modified Bovine Haemoglobin (Product codes: ERI-01-1000, ERI-01- 500, ERI-01-120)

Mycoplasma Hyopneumoniae Medium Product code 211271

NALFURAFINE (TRK-820) DRUG SUBSTANCE

NEO HELIOPAN OS

NEOMYCIN SULFATE AND NEOMYCIN SULFATE MICRONIZED

NEVIRAPINE

NIACIN USP

NIACINAMIDE USP

NILOTINIB HYDROCHLORIDE MONOHYDRATE

NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG

Naltrexone hydrochloride

Newborn Calf Serum

Norfloxacin

OLMESARTAN MEDOXOMIL USP

OXALIPLATIN

Olmesartan medoxomil

Omeprazole

Ossein Hydroxyapatite Compound

Oxfendazole For Veterinary Use

Oxytetracycline dihydrate

PALONOSETRON HYDROCHLORIDE

PANTAPRAZOLE SODIUM SESQUIHYDRATE

PANTOPRAZOLE SODIUM SESQUIHYDRATE

PANTOPRAZOLE SODIUM SESQUIHYDRATE USP

PAROXETINE STAGE 2 DL-AMINO ALCOHOL

PEMETREXED DISODIUM (NON STERILE)

PHARMACEUTICAL PROCESSING OF CEFMENOXINE HCL FOR INJECT -HIKARI PLANT

PHENELZINE SULFATE

PITAVASTATIN CALCIUM

PLEUROMUTILIN

PROCESSING OF OXENDOLONE AQUOSUSPENSOID INJ IN THE OSAKA PLANT

PYRIDOXINE HYDROCHLORIDE

Paroxetine hydrochloride hemihydrate

Phenoxymethylpenicillin potassium

Piracetam

Potassium clavulanate

Praziquantel

Prednisolone Hydrogen Succinate (or Prednisolone Hemisuccinate)

Prednisolone acetate

Primagen

Purified Haemoglobin Solution

Purified type I collagen material

Pyrazinamide

RHA

RIVAROXABAN (DRUG SUBSTANCE, NON-STERILE)

ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5)

ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3)

ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES

RU-COMPLEX SOLUTION

RUTHENIUM COMPLEX

Rabeprazole sodium

Racecadotril

Ramipril Process 2

Ranitidine hydrochloride Form - 2

Remifentanil hydrochloride

Riboflavin Fermentation process

Ribonuclease A

Rifampicin

Ropivacaine hydrochloride monohydrate

Rutoside trihydrate

SIMVASTATIN

SITAGLIPTIN PHOSPHATE

SITAGLIPTIN PHOSPHATE MONOHYDRATE

SODIUM DEACETYL CEPHALOSPORIN C (DCPE-Na) PRODUCTION IN HIKARI PLANT

SOLIFENACIN SUCCINATE

SPIRONOLACTONE USP BULK API

STERILE ANHYDROUS SODIUM CARBONATE

STERILE CEFOTIAM

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ROSSINI PLANT IN MILANO, ITALY

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN AMEEPET AND DUNDIGAL, INDIA

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CAGUAS, PUERTO RICO

STERILE WATER FOR INJECTION

SUCROSE OCTASULFATE, POTASSIUM SALT

SULINDAC SULFONE

Simvastatin

Sodium (S)-lactate solution

Sodium alendronate trihydrate

Sodium alginate

Sodium hyaluronate Intrinsic viscosity : not less than 1.2 m3/kg, by fermentation, for parenteral administration including intra-articular use and intra-ocular use

Sodium hydrogen carbonate

Sodium picosulfate

Sodium stearyl fumarate

Sodium valproate

Solifenacin succinate

Somatostatin

Starches, hydroxyethyl Mw 450, MS 0.7, C2/C6 5

Sulfamethoxazole

Sumatriptan succinate

TAK-536 DRUG SUBSTANCE

TAK-603

TAMOXIFEN CITRATE USP

TAMSULOSIN HYDROCHLORIDE

TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION

TAP-144-SR (1M)

TAP-144-SR (3M) (22.5MG.)

TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE)

TAP-144-SR(N) 7.5 AND 3.75 MG.

TELMISARTAN METHYL ESTER

TENOFOVIR DISOPROXIL FUMARATE

THIAMINE HYDROCHLORIDE

TNP-470

TRIBUTYL CITRATE

Teicoplanin Process A

Theophylline-ethylenediamine

Thioctic acid

Tiamulin hydrogen fumarate for veterinary use

Tiapride hydrochloride Process 2

Tirilazad

Tobramycin

Triamcinolone

Triamcinolone 3 (21-(acetyloxy)pregna-1,4,9(11)-16-tetraene-3,20-dione)

Triamcinolone 5 (9beta,11beta-Epoxy-16alpha,17alpha,21-trihydroxypregna-1,4-diene-3,20-dione)

Triamcinolone acetonide

Triamcinolone-21-acetate

Triflusal

Trimebutine maleate

Trimetazidine dihydrochloride

Tylosin for veterinary use

Tylosin tartrate for veterinary use

Ursodeoxycholic acid

VALSARTAN

VARENICLINE TARTRATE

VENLAFAXINE HYDROCHLORIDE

VITAMIN D3 (CHOLECALCIFEROL) WATER SOLUBLE 100 IU/MG

Vinblastine Sulfate

YMC * GEL

ZALEPLON

ZOLPIDEM TARTRATE

[2R-[2A,5A,6A(R

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Status - Active

Status - Inactive

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EXPIRED

SUSPENDED

VALID

WITHDRAWN BY EDQM

WITHDRAWN BY HOLDER

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217MF10442

217MF10539

217MF10978

218MF10447

218MF10470

218MF11023

218MF11033

219MF10056

219MF10120

220MF10037

220MF10132

222MF10213

223MF10162

224MF10007

224MF10076

224MF10143

225MF10135

226MF10074

226MF10099

226MF10107

226MF10121

226MF10170

226MF10233

227MF10120

227MF10151

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WC-0017

WC-0054

WC-0093

WC-0104

WC-0142

WC-0159

WC-0172

WC-0176

WC-0231

WC-0272

WC-237

WC-248

WC-272

WC-278

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
1,3 PROPANEDIOL 2 PHENYL
Issue/Submission Date
1991-06-11
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
1,3 PROPANEDIOL 2 PHENYL
Issue/Submission Date
1991-06-11
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
2,4-dichlorobenzyl alcohol
Issue/Submission Date
2016-04-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-248
Status
Valid - 2019-07-02
Filing Details
2,4 Dichlorobenzyl Alcohol
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-248
Status
VALID
 
Valid - 2019-07-02
Filing Details
2,4-dichlorobenzyl alcohol
2,4 Dichlorobenzyl Alcohol
Issue/Submission Date
2016-04-22
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
(2R, 3S)-2[(1R)-1-[3,5-BIS(TRIFLUOR...
Issue/Submission Date
2013-09-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
(2R, 3S)-2[(1R)-1-[3,5-BIS(TRIFLUOR...
Issue/Submission Date
2013-09-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
3990 ACID, PHARMACEUTICAL INTERMEDI...
Issue/Submission Date
2004-07-03
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
3990 ACID, PHARMACEUTICAL INTERMEDI...
Issue/Submission Date
2004-07-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
4-METHOXY-2,3,6-TRIMETHYLBENZALDEHY...
Issue/Submission Date
1991-05-03
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
4-METHOXY-2,3,6-TRIMETHYLBENZALDEHY...
Issue/Submission Date
1991-05-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
6,7- DIMETHOXY- 3,4- DIHYDROISOQUIN...
Issue/Submission Date
2016-01-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
6,7- DIMETHOXY- 3,4- DIHYDROISOQUIN...
Issue/Submission Date
2016-01-07
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
RUTHENIUM COMPLEX
Issue/Submission Date
2004-05-24
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
RUTHENIUM COMPLEX
Issue/Submission Date
2004-05-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
RU-COMPLEX SOLUTION
Issue/Submission Date
2007-03-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
RU-COMPLEX SOLUTION
Issue/Submission Date
2007-03-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
Filing Details
ABIRATERONE ACETATE
Issue/Submission Date
2014-07-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
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ABIRATERONE ACETATE
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2014-07-07
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ACAMPROSATE CALCIUM, NON-STERILE BU...
Issue/Submission Date
2010-08-25
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CEP/COS

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Issue/Submission Date
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Japanese DMF

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Written Confirmation

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Issue/Submission Date
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Status
Status - Inactive
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ACAMPROSATE CALCIUM, NON-STERILE BU...
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2010-08-25
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ACETYLTRI-N-HEXYL CITRATE (ATHC)
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1990-12-13
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Written Confirmation

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ACETYLTRI-N-HEXYL CITRATE (ATHC)
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1990-12-13
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CEP/COS

Application Number
Status
VALID
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Acetylcysteine
Issue/Submission Date
2009-04-23
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Japanese DMF

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Japanese Pharmacopoeia-acetylcystei...
Issue/Submission Date
2012-01-18
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Acetylcysteine
Japanese Pharmacopoeia-acetylcystei...
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2009-04-23
2012-01-18
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ACETYLTRIETHYL CITRATE
Issue/Submission Date
1989-03-31
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
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ACETYLTRIETHYL CITRATE
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1989-03-31
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USDMF

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CEP/COS

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WITHDRAWN BY HOLDER
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Aciclovir
Issue/Submission Date
2005-02-10
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Japanese DMF

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Aciclovir
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2005-02-10
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CEP/COS

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WITHDRAWN BY HOLDER
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Aciclovir
Issue/Submission Date
2011-03-15
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Japanese DMF

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Aciclovir
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2011-03-15
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CEP/COS

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Aciclovir
Issue/Submission Date
2013-04-18
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Japanese DMF

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Aciclovir
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2013-04-18
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Methoxy-C15-WITTIG Salt (TGN05), In...
Issue/Submission Date
2007-12-03
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
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Methoxy-C15-WITTIG Salt (TGN05), In...
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2007-12-03
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ADAPALENE (NON-STERILE BULK DRUG SU...
Issue/Submission Date
2005-09-22
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Written Confirmation

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Status
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Issue/Submission Date
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Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
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ADAPALENE (NON-STERILE BULK DRUG SU...
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2005-09-22
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CEP/COS

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Alanine
Issue/Submission Date
2018-02-14
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Status
 
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Alanine
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2018-02-14
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USDMF

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CEP/COS

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WITHDRAWN BY HOLDER
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Albendazole
Issue/Submission Date
2005-08-03
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Japanese DMF

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Status
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Status
WITHDRAWN BY HOLDER
 
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Albendazole
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2005-08-03
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USDMF

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CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
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Allopurinol
Issue/Submission Date
2004-10-13
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Japanese DMF

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Status
 
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Written Confirmation

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Status
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Issue/Submission Date
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Status
WITHDRAWN BY HOLDER
 
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Allopurinol
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2004-10-13
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USDMF

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CEP/COS

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Status
VALID
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Allopurinol
Issue/Submission Date
2017-05-16
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Japanese DMF

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Status
 
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Status
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Allopurinol
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2017-05-16
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USDMF

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CEP/COS

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Status
EXPIRED
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Alphamethyl Epoxide
Issue/Submission Date
2002-01-28
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Japanese DMF

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Status
 
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Written Confirmation

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Status
EXPIRED
 
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Alphamethyl Epoxide
Issue/Submission Date
2002-01-28
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USDMF

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Status
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CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
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Alprazolam
Issue/Submission Date
2001-12-19
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Japanese DMF

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Status
 
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Status
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Issue/Submission Date
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Status
WITHDRAWN BY HOLDER
 
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Alprazolam
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2001-12-19
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USDMF

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CEP/COS

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Status
VALID
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Aluminium oxide, hydrated 0325
Issue/Submission Date
2014-11-18
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Japanese DMF

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Status
 
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Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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Status
VALID
 
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Aluminium oxide, hydrated 0325
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2014-11-18
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CEP/COS

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Status
VALID
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Theophylline-ethylenediamine
Issue/Submission Date
2015-12-15
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Japanese DMF

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Status
 
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Written Confirmation

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Status
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Theophylline-ethylenediamine
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2015-12-15
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USDMF

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CEP/COS

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Status
VALID
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Amisulpride
Issue/Submission Date
2016-07-01
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Status
 
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Written Confirmation

Application Number
Indian CDSCO WC-0159
Status
Valid - 2019-07-02
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Amisulpride (EP/BP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0159
Status
VALID
 
Valid - 2019-07-02
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Amisulpride
Amisulpride (EP/BP)
Issue/Submission Date
2016-07-01
2016-07-12
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
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AMLODIPINE BESYLATE MONOHYDRATE
Issue/Submission Date
2005-10-11
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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AMLODIPINE BESYLATE MONOHYDRATE
Issue/Submission Date
2005-10-11
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USDMF

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CEP/COS

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Status
WITHDRAWN BY HOLDER
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Amoxicillin sodium Sterile, Process...
Issue/Submission Date
2003-09-09
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Japanese DMF

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Status
 
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Issue/Submission Date
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Status
WITHDRAWN BY HOLDER
 
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Amoxicillin sodium Sterile, Process...
Issue/Submission Date
2003-09-09
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USDMF

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Issue/Submission Date
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CEP/COS

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Status
WITHDRAWN BY EDQM
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Amoxicillin trihydrate Powder, comp...
Issue/Submission Date
2005-01-24
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Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
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Status
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Issue/Submission Date
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Status
WITHDRAWN BY EDQM
 
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Amoxicillin trihydrate Powder, comp...
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2005-01-24
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
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ANASTROLZOLE
Issue/Submission Date
2006-02-27
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CEP/COS

Application Number
Status
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Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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ANASTROLZOLE
Issue/Submission Date
2006-02-27
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
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APREPITANT (DRUG SUBSTANCE, NON-STE...
Issue/Submission Date
2012-01-17
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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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APREPITANT (DRUG SUBSTANCE, NON-STE...
Issue/Submission Date
2012-01-17
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APREPITANT
Issue/Submission Date
2014-12-05
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CEP/COS

Application Number
Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
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APREPITANT
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2014-12-05
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USDMF

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CEP/COS

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Status
VALID
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Aprotinin concentrated solution Act...
Issue/Submission Date
2016-02-02
Supporting Info
Japanese DMF

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Status
 
Filing Details
Aprotinin concentrate (production o...
Issue/Submission Date
2006-12-28
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Status
Filing Details
Issue/Submission Date
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Status
VALID
 
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Aprotinin concentrated solution Act...
Aprotinin concentrate (production o...
Issue/Submission Date
2016-02-02
2006-12-28
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USDMF

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CEP/COS

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Status
VALID
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Arginine hydrochloride
Issue/Submission Date
2017-02-20
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Status
 
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Issue/Submission Date
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Status
Filing Details
Issue/Submission Date
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Status
VALID
 
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Arginine hydrochloride
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2017-02-20
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USDMF

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Issue/Submission Date
Supporting Info
CEP/COS

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Status
VALID
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Aripiprazole
Issue/Submission Date
2015-12-10
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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Status
VALID
 
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Aripiprazole
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2015-12-10
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
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ARIPIPRAZOLE
Issue/Submission Date
2006-08-11
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
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ARIPIPRAZOLE
Issue/Submission Date
2006-08-11
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USDMF

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Status
Status - Active
Facility Fees - Unpaid
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ARIPIPRAZOLE
Issue/Submission Date
2011-05-12
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
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ARIPIPRAZOLE
Issue/Submission Date
2011-05-12
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USDMF

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Status
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Facility Fees - Paid
DMF Review - Complete
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ARSENIC TRIOXIDE
Issue/Submission Date
2017-01-31
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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ARSENIC TRIOXIDE
Issue/Submission Date
2017-01-31
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USDMF

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Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Ascorbic acid
Issue/Submission Date
2002-11-19
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
WITHDRAWN BY HOLDER
 
Filing Details
Ascorbic acid
Issue/Submission Date
2002-11-19
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
SUSPENDED
Filing Details
Ascorbic acid
Issue/Submission Date
2014-08-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
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Status
SUSPENDED
 
Filing Details
Ascorbic acid
Issue/Submission Date
2014-08-26
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USDMF

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Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
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ATAZANAVIR SULFATE
Issue/Submission Date
2015-03-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ATAZANAVIR SULFATE
Issue/Submission Date
2015-03-23
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN ATV44 (L1)
Issue/Submission Date
2005-10-04
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATORVASTATIN ATV44 (L1)
Issue/Submission Date
2005-10-04
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN SODIUM NON-STERILE BUL...
Issue/Submission Date
2007-05-06