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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dr. Reddys Laboratories

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1-METHYLAMINO-1-METHYTHIO-2-NITROETHENE(NMSM) CHEMICAL INTERMEDIATE

2,6-DIISOPROPYLPHENOL

20 KDA METHOXYPOLY(ETHYLENE GLYCOL) PROPIONALDEHYDE

20 KDA METHOXYPOLY(ETHYLENE GLYCOL)-4-NITROPHENYL CARBONATE

ABACAVIR

ABACAVIR SULPHATE

ABIRATERONE ACETATE

ACETAMINOPHEN

ALENDRONATE SODIUM

ALFUZOSIN HYDROCHLORIDE

AMLODIPINE BESILATE USP

AMLODIPINE MALEATE

ANASTROZOLE USP

APIXABAN

APREMILAST (FORM B)

APREMILAST [AMORPHOUS]

APREPITANT USP

ARIPIPRAZOLE

ASENAPINE MALEATE

ATOMOXETINE HYDROCHLORIDE USP

ATORVASTATIN CALCIUM (AMORPHOUS)

ATORVASTATIN CALCIUM (BUTYLATED HYDROXY ANISOLE PREMIX)

ATORVASTATIN CALCIUM (FORM P) USP, SEMICRYSTALLINE

ATORVASTATIN CALCIUM (NO BHA PREMIX)

ATORVASTATIN CALCIUM TRIHYDRATE (FORM I), USP

AZACITIDINE

Amsacrine (IH)

Atorvastatin Calcium Trihydrate (IH)

BAZEDOXIFENE ACETATE

BENDAMUSTINE HYDROCHLORIDE

BENZTROPINE MESYLATE USP

BICALUTAMIDE

BIVALIRUDIN

BORTEZOMIB

BROMFENAC SODIUM SESQUIHYDRATE

CABAZITAXEL

CANAGLIFLOZIN

CANDESARTAN CILEXETIL USP

CAPECITABINE USP

CAPECITABINE [PROCESS-II]

CARFILZOMIB

CARVEDILOL FORM-2

CARVEDILOL PHOSPHATE (AMORPHOUS)

CELECOXIB USP

CETIRIZINE DIHYDROCHLORIDE

CINACALCET HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, USP

CIPROFLOXACIN USP

CITALOPRAM HYDROBROMIDE USP

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE [FORM-I] USP

CLOPIDOGREL PREMIX

Cetirizine dihydrochloride Process II

Ciprofloxacin Hydrochloride

Clopidogrel Bisulphate (IH/USP)

Clopidogrel Hydrogen Sulfate (Ph. Eur.)

DABIGATRAN ETEXILATE MESYLATE

DAPAGLIFLOZIN (AMORPHOUS)

DAPAGLIFLOZIN PROPANEDIOL

DARIFENACIN HYDROBROMIDE

DASATINIB (S)-PROPYLENE GLYCOL

DECITABINE

DESLORATADINE

DEXLANSOPRAZOLE (AMORPHOUS)

DEXLANSOPRAZOLE (CRYSTALLINE)

DEXTROMETHORPHAN HYDROBROMIDE

DEXTROMETHORPHAN HYDROBROMIDE USP

DEXTROMETHORPHAN, USP

DILTIAZEM HYDROCHLORIDE

DIMETHYL FUMARATE

DISODIUM PAMIDRONATE

DIVALPROEX SODIUM USP

DOCETAXEL ANHYDROUS

DOMPERIDONE MALEATE

DONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP

DOXAZOSIN MESYLATE USP

DULOXETINE HYDROCHLORIDE

DUTASTERIDE (PROCESS-II)

DUTASTERIDE (Process-I)

Diltiazem hydrochloride

Domperidone

Donepezil Hydrochloride Monohydrate (IH)

ELIGLUSTAT TARTRATE

EMPAGLIFLOZIN

EMPAGLIFLOZIN (AMORPHOUS)

ENALAPRIL MALEATE, USP

ENALAPRILAT, USP

ENZALUTAMIDE

ESCITALOPRAM OXALATE

ESCITALOPRAM OXALATE (PROCESS II)

ESLICARBAZEPINE ACETATE

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS FORM)

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3]

ESOMEPRAZOLE MAGNESIUM AMORPHOUS (PROCESS-2) USP

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE [PRODUCT CODE: ERM]

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP

ESOMEPRAZOLE MAGNESIUM [AMORPHOUS] [PRODUCT CODE: ADR]

ESTRADIOL

ESZOPICLONE

ESZOPICLONE [PROCESS-3]

EXEMESTANE

EZETIMIBE USP

Enalapril Maleate (Ph. Eur./ USP)

FAMOTIDINE USP

FEBUXOSTAT

FEXOFENADINE HYDROCHLORIDE

FINASTERIDE (FORM I)

FINASTERIDE USP (FORM III)

FINGOLIMOD HYDROCHLORIDE

FLUCONAZOLE (FORM 2)

FLUNISOLIDE

FLUNISOLIDE HEMIHYDRATE

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE ACETATE

FLUOXETINE HYDROCHLORIDE, USP

FONDAPARINUX SODIUM USP

FOSAPREPITANT DIMEGLUMINE

FOSPHENYTOIN SODIUM

Famotidine (Form-A) USP

Flecainide acetate

Fluoxetine hydrochloride

GALANTAMINE HYDROBROMIDE

GATIFLOXACIN ANHYDROUS

GEMCITABINE HYDROCHLORIDE USP

GLATIRAMER ACETATE

GLIMEPIRIDE USP

GRANISETRON

IBANDRONATE SODIUM (FORM-BETA)

IBANDRONATE SODIUM MONOHYDRATE

IBRUTINIB

IBUPROFEN

ICATIBANT ACETATE

IMATINIB MESYLATE

INGENOL MEBUTATE

IRBESARTAN USP

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

IRON SUCROSE

Ibandronate Sodium Monohydrate (IH)

KETOROLAC TROMETHAMINE USP

L-METHYL DOPA

LACOSAMIDE

LAMOTRIGINE

LANSOPRAZOLE FORM-1

LENALIDOMIDE

LENALIDOMIDE (POVIDONE PREMIX)

LENALIDOMIDE DIMETHYLFORMAMIDE SOLVATE

LENVATINIB MESYLATE (MIBK SOLVATE)

LETROZOLE

LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCLORIDE USP

LEVOFLOXACIN HEMIHYDRATE USP

LIFITEGRAST

LINAGLIPTIN

LINEZOLID

LOMUSTINE USP

LOPINAVIR

LORCASERIN HYDROCHLORIDE HEMIHYDRATE

LOSARTAN POTASSIUM FORM-1

LUBIPROSTONE

LURASIDONE HYDROCHLORIDE

Lacidipine (BP)

Levofloxacin Hemihydrate (IH)

MELOXICAM

MEMANTINE HYDROCHLORIDE USP

MESALAMINE

METOPROLOL SUCCINATE USP

MILNACIPRAN HYDROCHLORIDE

MIRABEGRON PREMIX

MIRABEGRON [FORM - AMORPHOUS]

MIRABEGRON [PRODUCT CODE: AEB]

MONTELUKAST SODIUM USP

MONTELUKAST SODIUM [PROCESS-2]

MOXIFLOXACIN HYDROCHLORIDE USP

Moxifloxacin hydrochloride

NAPROXEN

NAPROXEN SODIUM

NARATRIPTAN HYDROCHLORIDE

NATEGLINIDE (PREMIX)

NEBIVOLOL HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE

NILOTINIB HYDROCHLORIDE

NIZATIDINE USP

Norethindrone

Norfloxacin

O-DESMETHYL VENLAFAXINE

O-DESMETHYL VENLAFAXINE SUCCINATE (AMORPHOUS)

OBETICHOLIC ACID

OLANZAPINE (FORM 1), USP

OLMESARTAN MEDOXOMIL

OLMESARTAN MEDOXOMIL USP (PROCESS II)

OMEPRAZOLE (FORM B) USP

OMEPRAZOLE [PROCESS-II]

OMEPRAZOLE, USP

Sodium alendronate trihydrate

TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYANO-2-AZABICYCLO[3.1.0]HEXAN-2-YL)1-((1R, 3R,5R,7S)-3-HYDROXYADAMANTAN-1-YL)-2-OXOETHYL)CARBAMATE

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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218MF10215

218MF10306

218MF10821

218MF11007

219MF10126

219MF10202

219MF10208

219MF10352

220MF10243

222MF10263

223MF10018

226MF10020

226MF10041

226MF10045

226MF10054

226MF10068

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WC-0026

WC-0034

WC-0035

WC-0039

WC-0043

WC-0067

WC-0390

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
1-METHYLAMINO-1-METHYTHIO-2-NITROET...
Issue/Submission Date
1999-09-23
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 - Paid
DMF Review - N/A
 
Filing Details
1-METHYLAMINO-1-METHYTHIO-2-NITROET...
Issue/Submission Date
1999-09-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
2,6-DIISOPROPYLPHENOL
Issue/Submission Date
1994-03-22
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
2,6-DIISOPROPYLPHENOL
Issue/Submission Date
1994-03-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ABACAVIR
Issue/Submission Date
2010-12-07
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
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Abacavir (IH)
Issue/Submission Date
2016-08-03
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ABACAVIR
Abacavir (IH)
Issue/Submission Date
2010-12-07
2016-08-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ABACAVIR SULPHATE
Issue/Submission Date
2011-02-21
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
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Abacavir Sulehate IH
Issue/Submission Date
2016-12-28
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ABACAVIR SULPHATE
Abacavir Sulehate IH
Issue/Submission Date
2011-02-21
2016-12-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ABIRATERONE ACETATE
Issue/Submission Date
2014-03-27
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 - Complete
 
Filing Details
ABIRATERONE ACETATE
Issue/Submission Date
2014-03-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ACETAMINOPHEN
Issue/Submission Date
1999-12-16
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
ACETAMINOPHEN
Issue/Submission Date
1999-12-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALENDRONATE SODIUM
Issue/Submission Date
2006-12-29
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
Indian CDSCO WC-0035
Status
Expired - 2016-05-06
Filing Details
Sodium Alendronate (Ph. Eur.)
Issue/Submission Date
2013-06-06
Supporting Info
Application Number
Indian CDSCO WC-0035
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-05-06
Filing Details
ALENDRONATE SODIUM
Sodium Alendronate (Ph. Eur.)
Issue/Submission Date
2006-12-29
2013-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALFUZOSIN HYDROCHLORIDE
Issue/Submission Date
2006-11-14
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
ALFUZOSIN HYDROCHLORIDE
Issue/Submission Date
2006-11-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMLODIPINE BESILATE USP
Issue/Submission Date
2003-03-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amlodipine besilate
Issue/Submission Date
2017-08-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Amlodipine besylate at 8-2-337, Roa...
Issue/Submission Date
2007-12-10
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0035
Status
Expired - 2016-05-06
Filing Details
Amlodipine Besylate (Ph. Eur.)
Issue/Submission Date
2013-06-06
Supporting Info
Application Number
Indian CDSCO WC-0035
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Expired - 2016-05-06
Filing Details
AMLODIPINE BESILATE USP
Amlodipine besilate
Amlodipine besylate at 8-2-337, Roa...
Amlodipine Besylate (Ph. Eur.)
Issue/Submission Date
2003-03-19
2017-08-23
2007-12-10
2013-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMLODIPINE MALEATE
Issue/Submission Date
2001-12-03
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
Indian CDSCO WC-0035
Status
Expired - 2016-05-06
Filing Details
 Amlodipine Maleate (IH)
Issue/Submission Date
2013-06-06
Supporting Info
Application Number
Indian CDSCO WC-0035
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-05-06
Filing Details
AMLODIPINE MALEATE
 Amlodipine Maleate (IH)
Issue/Submission Date
2001-12-03
2013-06-06
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
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
Indian CDSCO WC-0039
Status
Expired - 2019-06-05
Filing Details
Amsacrine (IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0039
Status
 
Expired - 2019-06-05
Filing Details
Amsacrine (IH)
Issue/Submission Date
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ANASTROZOLE USP
Issue/Submission Date
2007-01-16
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
ANASTROZOLE at 8-2-337, Road No. 3,...
Issue/Submission Date
2011-02-03
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Anastrozole (IH/USP)
Issue/Submission Date
2016-08-03
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ANASTROZOLE USP
ANASTROZOLE at 8-2-337, Road No. 3,...
Anastrozole (IH/USP)
Issue/Submission Date
2007-01-16
2011-02-03
2016-08-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APIXABAN
Issue/Submission Date
2015-09-22
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 - Complete
 
Filing Details
APIXABAN
Issue/Submission Date
2015-09-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST (FORM B)
Issue/Submission Date
2016-09-30
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 - Complete
 
Filing Details
APREMILAST (FORM B)
Issue/Submission Date
2016-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST [AMORPHOUS]
Issue/Submission Date
2017-06-02
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 - Complete
 
Filing Details
APREMILAST [AMORPHOUS]
Issue/Submission Date
2017-06-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREPITANT USP
Issue/Submission Date
2008-02-18
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
Indian CDSCO WC-0035
Status
Expired - 2016-05-06
Filing Details
Aprepitant (IH)
Issue/Submission Date
2013-06-06
Supporting Info
Application Number
Indian CDSCO WC-0035
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Expired - 2016-05-06
Filing Details
APREPITANT USP
Aprepitant (IH)
Issue/Submission Date
2008-02-18
2013-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARIPIPRAZOLE
Issue/Submission Date
2005-06-30
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
ARIPIPRAZOLE
Issue/Submission Date
2005-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ASENAPINE MALEATE
Issue/Submission Date
2012-03-26
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
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Asenapine Maleate IH
Issue/Submission Date
2016-12-28
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
ASENAPINE MALEATE
Asenapine Maleate IH
Issue/Submission Date
2012-03-26
2016-12-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2005-06-22
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
Indian CDSCO WC-0035
Status
Expired - 2016-05-06
Filing Details
Atomoxetine Hydrochloride (IH)
Issue/Submission Date
2013-06-06
Supporting Info
Application Number
Indian CDSCO WC-0035
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-05-06
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Atomoxetine Hydrochloride (IH)
Issue/Submission Date
2005-06-22
2013-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATORVASTATIN CALCIUM (AMORPHOUS)
Issue/Submission Date
2005-06-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Atorvastatin calcium trihydrate For...
Issue/Submission Date
2018-06-28
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
ATORVASTATIN CALCIUM TRIHYDRATE FOR...
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2014-01-21
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ATORVASTATIN CALCIUM (AMORPHOUS)
Atorvastatin calcium trihydrate For...
ATORVASTATIN CALCIUM TRIHYDRATE FOR...
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2005-06-29
2018-06-28
2014-01-21
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ATORVASTATIN CALCIUM (FORM P) USP, ...
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2006-11-27
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CEP/COS

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Japanese DMF

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ATORVASTATIN CALCIUM (FORM P) USP, ...
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2006-11-27
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ATORVASTATIN CALCIUM (NO BHA PREMIX...
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2007-12-14
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ATORVASTATIN CALCIUM (NO BHA PREMIX...
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2007-12-14
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ATORVASTATIN CALCIUM TRIHYDRATE (FO...
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2010-03-30
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ATORVASTATIN CALCIUM TRIHYDRATE (FO...
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2010-03-30
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ATORVASTATIN CALCIUM (BUTYLATED HYD...
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2012-03-23
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ATORVASTATIN CALCIUM (BUTYLATED HYD...
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2012-03-23
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CEP/COS

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Indian CDSCO WC-0034
Status
Expired - 2019-06-05
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Atorvastatin Calcium Trihydrate (IH...
Issue/Submission Date
2016-08-05
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Application Number
Indian CDSCO WC-0034
Status
 
Expired - 2019-06-05
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Atorvastatin Calcium Trihydrate (IH...
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2016-08-05
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AZACITIDINE
Issue/Submission Date
2010-02-23
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Indian CDSCO WC-0039
Status
Expired - 2019-06-05
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Azacitidine (IH)
Issue/Submission Date
2016-06-23
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Application Number
Indian CDSCO WC-0039
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2019-06-05
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AZACITIDINE
Azacitidine (IH)
Issue/Submission Date
2010-02-23
2016-06-23
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BAZEDOXIFENE ACETATE
Issue/Submission Date
2012-03-30
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Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Bazedoxifene Acetate (IH)
Issue/Submission Date
2016-12-28
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
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BAZEDOXIFENE ACETATE
Bazedoxifene Acetate (IH)
Issue/Submission Date
2012-03-30
2016-12-28
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BENDAMUSTINE HYDROCHLORIDE
Issue/Submission Date
2011-03-30
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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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Application Number
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Bendamustine HCI (IH)
Issue/Submission Date
2016-08-03
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Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
BENDAMUSTINE HYDROCHLORIDE
Bendamustine HCI (IH)
Issue/Submission Date
2011-03-30
2016-08-03
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USDMF

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Status
Status - Active
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BENZTROPINE MESYLATE USP
Issue/Submission Date
1987-06-18
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Japanese DMF

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Status
 
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Status
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DMF Review - N/A
 
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BENZTROPINE MESYLATE USP
Issue/Submission Date
1987-06-18
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USDMF

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Status
Status - Inactive
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BICALUTAMIDE
Issue/Submission Date
2006-09-19
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Status
 
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Status
Status - Inactive
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DMF Review - N/A
 
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BICALUTAMIDE
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2006-09-19
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USDMF

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BIVALIRUDIN
Issue/Submission Date
2010-03-23
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Status
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BIVALIRUDIN
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2010-03-23
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USDMF

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TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYAN...
Issue/Submission Date
2013-09-12
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Status
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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYAN...
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2013-09-12
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USDMF

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Status
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BORTEZOMIB
Issue/Submission Date
2010-07-26
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CEP/COS

Application Number
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

Application Number
Indian CDSCO WC-0039
Status
Expired - 2019-06-05
Filing Details
Bortezomib (IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0039
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2019-06-05
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BORTEZOMIB
Bortezomib (IH)
Issue/Submission Date
2010-07-26
2016-06-23
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USDMF

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Status
Status - Inactive
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DMF Review - N/A
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BROMFENAC SODIUM SESQUIHYDRATE
Issue/Submission Date
2011-08-11
Supporting Info
CEP/COS

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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 - Paid
DMF Review - N/A
 
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BROMFENAC SODIUM SESQUIHYDRATE
Issue/Submission Date
2011-08-11
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USDMF

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Status
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DMF Review - Complete
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CABAZITAXEL
Issue/Submission Date
2014-02-18
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
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Application Number
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Cabazitaxel IH
Issue/Submission Date
2016-12-28
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
CABAZITAXEL
Cabazitaxel IH
Issue/Submission Date
2014-02-18
2016-12-28
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USDMF

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Status
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CANAGLIFLOZIN
Issue/Submission Date
2016-09-30
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CEP/COS

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Status
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Status
 
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Status
Filing Details
Issue/Submission Date
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Application Number
Status
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Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-09-30
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Status
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CANDESARTAN CILEXETIL USP
Issue/Submission Date
2006-11-22
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Candesartan cilexetil
Issue/Submission Date
2015-10-09
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Candesartan Cilexetil (Ph. Eur.)
Issue/Submission Date
2016-08-03
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CANDESARTAN CILEXETIL USP
Candesartan cilexetil
Candesartan Cilexetil (Ph. Eur.)
Issue/Submission Date
2006-11-22
2015-10-09
2016-08-03
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USDMF

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Status
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CAPECITABINE USP
Issue/Submission Date
2009-01-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Capecitabine
Issue/Submission Date
2017-02-20
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0043
Status
Expired - 2019-06-05
Filing Details
Capecitabine (USP
Issue/Submission Date
2016-10-05
Supporting Info
Application Number
Indian CDSCO WC-0043
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Expired - 2019-06-05
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine (USP
Issue/Submission Date
2009-01-30
2017-02-20
2016-10-05
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
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CAPECITABINE [PROCESS-II]
Issue/Submission Date
2014-09-02
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Capecitabine
Issue/Submission Date
2015-05-19
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0067
Status
Valid - 2019-07-02
Filing Details
Capecitabine (USP/IH)
Issue/Submission Date
2016-08-03
Supporting Info
Application Number
Indian CDSCO WC-0067
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CAPECITABINE [PROCESS-II]
Capecitabine
Capecitabine (USP/IH)
Issue/Submission Date
2014-09-02
2015-05-19
2016-08-03
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USDMF

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Status
Status - Active
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CARFILZOMIB
Issue/Submission Date
2016-03-29
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
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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
CARFILZOMIB
Issue/Submission Date
2016-03-29
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USDMF

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Status
Status - Active
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CARVEDILOL FORM-2
Issue/Submission Date
2003-01-29
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Carvedilol
Issue/Submission Date
2015-10-08
Supporting Info
Japanese DMF

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Status
 
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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
WITHDRAWN BY HOLDER
 
Filing Details
CARVEDILOL FORM-2
Carvedilol
Issue/Submission Date
2003-01-29
2015-10-08
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARVEDILOL PHOSPHATE (AMORPHOUS)
Issue/Submission Date
2008-09-24
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 - Paid
DMF Review - N/A
 
Filing Details
CARVEDILOL PHOSPHATE (AMORPHOUS)
Issue/Submission Date
2008-09-24
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CELECOXIB USP
Issue/Submission Date
2008-09-02
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
CELECOXIB USP
Issue/Submission Date
2008-09-02
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USDMF

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

Application Number
Status
VALID
Filing Details
Cetirizine dihydrochloride Process ...
Issue/Submission Date
2017-07-07
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
VALID
 
Filing Details
Cetirizine dihydrochloride Process ...
Issue/Submission Date
2017-07-07
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CETIRIZINE DIHYDROCHLORIDE
Issue/Submission Date
2005-05-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cetirizine dihydrochloride
Issue/Submission Date
2018-10-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
CETIRIZINE DIHYDROCHLORIDE EP at 8-...
Issue/Submission Date
2006-04-20
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0039
Status
Expired - 2019-06-05
Filing Details
Cetirizine Di Hydrochloride (Ph. Eu...
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0039