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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

(2R,3R)-2-(2,4-DIFLUOROPHENYL)-1-(1H-1,2,4-TRIAZOL-1-YL)BUTANE-2,3-DIOL

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

1,2-dihydrotriamcinolone

1,3 PROPANEDIOL 2 PHENYL

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

2,4-WING 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

2-ISOPROPYL-4-(N-METHYL) AMINOMETHYLTHIAZOYLCARBONYL-(L)-VALINE

2-ISOPROPYL-4-(N-METHYL) AMNINOMETHYLTHIAZOLE

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

ABIRATERONE ACETATE

ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE

ACETYLTRI-N-BUTYL CITRATE

ACETYLTRI-N-HEXYL CITRATE (ATHC)

ACETYLTRIETHYL CITRATE

ACYCLOVIR

ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)

AG 1346

ALBENDAZOLE

ALLOPURINOL

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

BUPROPION HYDROCHLORIDE USP

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)

Bicalutamide

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

CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL USP

CARBIDOPA (NON-STERILE, BULK FORM)

CARISOPRODOL

CARISOPRODOL USP

CARVEDILOL PHOSPHATE

CELECOXIB

CELECOXIB, USP

CETYLPYRIDINIUM CHLORIDE USP

CHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

CHOLECALCIFEROL

CHROMIUM (III) PICOLINATE

CILOSTAZOL

CIMETIDINE

CIMETIDINE USP

CINACALCET HYDROCHLORIDE

CIPROFLAXIN HCL

CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, USP

CLINDAMYCIN HYDROCHLORIDE USP

CLINDAMYCIN PHOSPHATE USP

CLINDAMYCIN PHOSPHATE USP (AR)

CLOPIDOGREL BISULFATE

COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP

CRUDE HEPARIN SODIUM

CS-526 DRUG SUBSTANCE

CS-615 DRUG SUBSTANCE

CS-747 DRUG SUBSTANCE

CYCLOPENTOLATE HYDROCHLORIDE

Caffeine

Calcitonin (salmon) Sterile - Synthetic Origin

Calcium carbonate

Calf Serum

Carbidopa

Carbocisteine

Carboplatin

Carvedilol

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

DAPTOMYCIN

DEFERASIROX

DEXLANSOPRAZOLE

DORZOLAMIDE HYDROCHLORIDE

DOXYLAMINE SUCCINATE USP

DS-1442B DRUG SUBSTANCE

DULOXETINE HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

Dacarbazine

Defibrinated calf blood

Deoxyribonuclease I

Dexamethasone

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)

ENOXAPARIN SODIUM USP

EPTIFIBATIDE

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE)

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

Etamsylate

Exemestane

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

FAMOTIDINE USP

FEBUXOSTAT

FELBAMATE

FELODIPINE

FENOFIBRATE USP

FERRIC CITRATE

FERROUS ASCORBATE

FERROUS GLYCINE SULPHATE

FLUOROSULFONYLETHANONE

FLUOXETINE HCL USP

FLUOXETINE HYDROCHLORIDE, USP

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

GATIFLOXACIN HEMIHYDRATE

GEMCITABINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

GEMFIBROZIL USP

GLIMEPIRIDE

GLIMEPIRIDE NON-STERILE BULK DRUG SUBSTANCE

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

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

HYDROCORTISONE BASE USP BULK API

HYDROMORPHONE HYDROCHLORIDE

HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG

Haloperidol

Heptaminol hydrochloride

Hydrocortisone acetate

Hydrocortisone hydrogen succinate

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

INTERMEDIATE FOR MONTANIDE ISA 50

IOPAMIDOL STEP #1

IRON (III) HYDROXIDE POLYMALTOSE COMPLEX

Indapamide Standard and micronised

Isoniazid

Isosorbide mononitrate, diluted

Itraconazole

KETOCONAZOLE

KETOROLAC TROMETHAMINE USP

KETOSULFONE

Ketoconazole

L-Ala-pAF-OH HCl

L-METHIONINE SULFOXIMINE

LABETALOL HYDROCHLORIDE

LAMOTRIGINE

LANSOPRAZOLE

LANSOPRAZOLE USP

LANSOPRAZOLE, NON-STERILE DRUG SUBSTANCE

LEVETIRACETAM

LEVODOPA

LEVOFLOXACIN HEMIHYDRATE

LEVONORGESTREL USP 23

LINAGLIPTIN

LINEZOLID

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

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

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN.

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

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CIMETIDINE USP IN BARCELONA, SPAIN.

MECLIZINE HYDROCHLORIDE USP

MELOXICAM

MEMANTINE HYDROCHLORIDE

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

MINOCYCLINE HYDROCHLORIDE USP

MIVACURIUM CHLORIDE

MODAFINIL

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)

Moxifloxacin hydrochloride

Mycoplasma Hyopneumoniae Medium Product code 211271

NALFURAFINE (TRK-820) DRUG SUBSTANCE

NEOMYCIN SULFATE AND NEOMYCIN SULFATE MICRONIZED

NEVIRAPINE

NIACIN USP

NIACINAMIDE USP

NIMODIPINE (MICRONIZED)

NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG

Netilmicin Sulfate

Newborn Calf Serum

Norfloxacin

OLMESARTAN MEDOXOMIL USP

OMEPRAZOLE

OMEPRAZOLE (SIEVED)

Olmesartan medoxomil

Omeprazole

Ossein Hydroxyapatite Compound

Oxfendazole For Veterinary Use

Oxytetracycline dihydrate

PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM SESQUIHYDRATE USP

PAROXETINE STAGE 2 DL-AMINO ALCOHOL

PENTAACETYLIOPAMIDOL

PHARMACEUTICAL PROCESSING OF CEFMENOXINE HCL FOR INJECT -HIKARI PLANT

PHENELZINE SULFATE

PITAVASTATIN CALCIUM

PLEUROMUTILIN

PYRANTEL PAMOATE

PYRANTEL PAMOATE USP

PYRANTEL TARTRATE ZEOLEX

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

QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM

RANITIDINE BASE

RANITIDINE HCL

RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM 1)

RANOLAZINE

RIVAROXABAN

RIVAROXABAN (DRUG SUBSTANCE, NON-STERILE)

ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5)

ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3)

ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES

Rabeprazole sodium

Rabeprazole sodium hydrate Form-Y (RKY-process)

Racecadotril

Ramipril Process 2

Ranitidine hydrochloride Form - 2

Remifentanil hydrochloride

Riboflavin Fermentation process

Ribonuclease A

Rifampicin

Rutoside trihydrate

SACUBITRIL SODIUM

SITAGLIPTIN PHOSPHATE

SITAGLIPTIN PHOSPHATE MONOHYDRATE

SOLIFENACIN SUCCINATE

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

TAMOXIFEN CITRATE USP

TELMISARTAN

TELMISARTAN METHYL ESTER

TENOFOVIR DISOPROXIL FUMARATE

TERBINAFINE HYDROCHLORIDE

THIAMINE HYDROCHLORIDE

TOLTERODINE TARTRATE

TRIBUTYL CITRATE

TROPICAMIDE

Teicoplanin Process A

Theophylline-ethylenediamine

Thioctic acid

Tiamulin hydrogen fumarate for veterinary use

Tiapride hydrochloride Process 2

Tirilazad

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

VALSARTAN DISODIUM

VARENICLINE TARTRATE

VENLAFAXINE HYDROCHLORIDE

YMC * GEL

YMC-TRIART

ZALEPLON

ZOLPIDEM TARTRATE

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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

218MF10349

218MF10434

218MF10447

218MF10470

218MF10711

218MF11023

219MF10056

219MF10080

219MF10120

219MF10283

220MF10103

220MF10132

222MF10213

223MF10162

224MF10007

224MF10076

224MF10143

225MF10135

226MF10069

226MF10074

226MF10099

226MF10107

226MF10170

226MF10201

226MF10233

227MF10120

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WC-0017

WC-0054

WC-0093

WC-0104

WC-0142

WC-0159

WC-0172

WC-0176

WC-0231

WC-237

WC-248

WC-272

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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
(2R,3R)-2-(2,4-DIFLUOROPHENYL)-1-(1...
Issue/Submission Date
2018-11-10
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,3R)-2-(2,4-DIFLUOROPHENYL)-1-(1...
Issue/Submission Date
2018-11-10
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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
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
2-ISOPROPYL-4-(N-METHYL) AMNINOMETH...
Issue/Submission Date
1995-08-09
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 - Paid
DMF Review - N/A
 
Filing Details
2-ISOPROPYL-4-(N-METHYL) AMNINOMETH...
Issue/Submission Date
1995-08-09
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
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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
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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
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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 - 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
 
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Issue/Submission Date
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Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
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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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Application Number
Status
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ACAMPROSATE CALCIUM, NON-STERILE BU...
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ACETYLTRI-N-HEXYL CITRATE (ATHC)
Issue/Submission Date
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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Status
 
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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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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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Issue/Submission Date
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Japanese DMF

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ACETYLTRIETHYL CITRATE
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1989-03-31
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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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Aciclovir
Issue/Submission Date
2011-03-15
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Aciclovir
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2011-03-15
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CEP/COS

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Aciclovir
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2013-04-18
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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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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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ACYCLOVIR
Issue/Submission Date
1996-03-18
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Issue/Submission Date
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ACYCLOVIR
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1996-03-18
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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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Issue/Submission Date
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Status
Status - Inactive
Facility Fees - Paid
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ADAPALENE (NON-STERILE BULK DRUG SU...
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2005-09-22
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USDMF

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AG 1346
Issue/Submission Date
1997-01-14
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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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Status
Filing Details
Issue/Submission Date
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Status
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AG 1346
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1997-01-14
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CEP/COS

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Status
VALID
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Alanine
Issue/Submission Date
2018-02-14
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Japanese DMF

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Status
 
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Issue/Submission Date
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Status
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Alanine
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2018-02-14
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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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Albendazole
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2005-08-03
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ALBENDAZOLE
Issue/Submission Date
2012-03-27
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Application Number
Status
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ALBENDAZOLE
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2012-03-27
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CEP/COS

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Allopurinol
Issue/Submission Date
2004-10-13
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Status
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Allopurinol
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2004-10-13
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CEP/COS

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Allopurinol
Issue/Submission Date
2017-05-16
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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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ALLOPURINOL
Issue/Submission Date
2003-03-19
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Status
VALID
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Allopurinol
Issue/Submission Date
2017-12-15
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Filing Details
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Application Number
Status
Status - Active
Facility Fees - Paid
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VALID
 
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ALLOPURINOL
Allopurinol
Issue/Submission Date
2003-03-19
2017-12-15
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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
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Alphamethyl Epoxide
Issue/Submission Date
2002-01-28
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USDMF

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CEP/COS

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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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Alprazolam
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2001-12-19
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CEP/COS

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Status
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Aluminium oxide, hydrated 0325
Issue/Submission Date
2014-11-18
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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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Theophylline-ethylenediamine
Issue/Submission Date
2015-12-15
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Theophylline-ethylenediamine
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2015-12-15
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Amisulpride
Issue/Submission Date
2016-07-01
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Application Number
Indian CDSCO WC-0159
Status
Valid - 2019-07-02
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Amisulpride (EP/BP)
Issue/Submission Date
2016-07-12
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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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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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Status
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Amoxicillin sodium Sterile, Process...
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2003-09-09
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CEP/COS

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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
 
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Issue/Submission Date
Supporting Info
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Status
Filing Details
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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APREPITANT (DRUG SUBSTANCE, NON-STE...
Issue/Submission Date
2012-01-17
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CEP/COS

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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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Status
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APREPITANT
Issue/Submission Date
2014-12-05
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CEP/COS

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Status
Filing Details
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
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Status
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APREPITANT
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2014-12-05
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CEP/COS

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

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Status
 
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Aprotinin concentrate (production o...
Issue/Submission Date
2006-12-28
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Application Number
Status
Filing Details
Issue/Submission Date
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Status
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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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CEP/COS

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Status
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Arginine hydrochloride
Issue/Submission Date
2017-02-20
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Status
 
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Issue/Submission Date
Supporting Info
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Status
Filing Details
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Status
VALID
 
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Arginine hydrochloride
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2017-02-20
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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
Filing Details
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Status
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Aripiprazole
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2015-12-10
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Status
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ARIPIPRAZOLE
Issue/Submission Date
2011-05-12
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CEP/COS

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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 - Active
Facility Fees - Unpaid
DMF Review - N/A
 
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ARIPIPRAZOLE
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2011-05-12
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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

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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 - Active
Facility Fees - Paid
DMF Review - Complete
 
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ARSENIC TRIOXIDE
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2017-01-31
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CEP/COS

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

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
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Status
Filing Details
Issue/Submission Date
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Status
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Ascorbic acid
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2014-08-26
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USDMF

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