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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Aurobindo Pharma Limited

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6 AMINO PENICILLANIC ACID

6-AMINO PENICILLANIC ACID DRUG SUBSTANCE INTERMEDIATE

7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA)

ABACAVIR SULFATE USP

ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE)

ALFUZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE USP

AMOXICILLIN SODIUM (STERILE) BULK

AMOXICILLIN USP

AMOXICILLIN USP (ENZYME ROUTE)

AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1)

AMPICILLIN SODIUM USP (STERILE) BULK

AMPICILLIN TRIHYDRATE, USP

APIXABAN

APREMILAST

ARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE)

ARMODAFINIL

ATAZANAVIR SULFATE (NON-STERILE DRUG SUBSTANCE)

ATOMOXETINE HYDROCHLORIDE USP

ATORVASTATIN CALCIUM (AMORPHOUS)

ATOVAQUONE USP

Abacavir Sulfate

Amisulpride

Amoxicillin Sodium (Sterile) (BP/Ph. Eur)

Amoxicillin Trihydrate (Ph. Eur)

Amoxicillin trihydrate

Amoxicillin trihydrate Enzymatic process

Atomoxetine Hydrochloride

Atomoxetine Hydrochloride (Ph. Eur)

Atorvastatin calcium trihydrate

BENAZEPRIL HYDROCHLORIDE USP

BISOPROLOL FUMARATE USP

BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)

BUPROPION HYDROCHLORIDE USP

Betahistine dihydrochloride

CANAGLIFLOZIN

CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE)

CARISOPRODOL USP

CARMUSTINE USP

CARVEDILOL USP

CEFACLOR USP

CEFADROXIL USP

CEFAZOLIN SODIUM USP

CEFDINIR USP (CRYSTAL B)

CEFEPIME FOR INJECTION USP (STERILE BULK)

CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE

CEFIXIME USP (NON-STERILE DRUG SUBSTANCE)

CEFOTAXIME SODIUM (STERILE)

CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

CEFOXITIN SODIUM USP (STERILE BULK)

CEFPODOXIME PROXETIL USP

CEFPROZIL USP

CEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATE

CEFTAZIDIME FOR INJECTION USP (STERILE BULK)

CEFTRIAXONE SODIUM

CEFTRIAXONE SODIUM (STERILE)

CEFUROXIME ACID

CEFUROXIME AXETIL USP

CEFUROXIME SODIUM

CEFUROXIME SODIUM (STERILE) USP

CELECOXIB USP

CEPHALEXIN USP

CEPHALOTHIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

CILASTATIN SODIUM USP (STERILE)

CINACALCET HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE USP

CITALOPRAM HYDROBROMIDE USP

CITALOPRAM HYDROBROMIDE USP (ROUTE-1)

CLINDAMYCIN HYDROCHLORIDE USP

CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

CLOPIDOGREL BISULFATE USP

COLESEVELAM HYDROCHLORIDE

Candesartan cilexetil Process-2

Carbimazole

Cefalexin (BP/EP/USP)

Cefalexin monohydrate

Cefixime

Ceftiofur Hydrochloride (IH)

Celecoxib (Ph. Eur)

Cloxacillin Sodium (BP/Ph. Eur)

Cloxacillin sodium

DABIGATRAN ETEXILATE MESYLATE

DALFAMPRIDINE

DAPAGLIFLOZIN

DARIFENACIN HYDROBROMIDE

DARUNAVIR PROPYLENE GLYCOLATE

DESMOPRESSIN ACETATE USP

DEXTROMETHORPHAN HYDROBROMIDE USP

DICHLORPHENAMIDE USP

DICLOXACILLIN SODIUM USP

DIDANOSINE USP

DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE

DIMETHYL FUMARATE

DIVALPROEX SODIUM USP

DOFETILIDE USP

DOLUTEGRAVIR SODIUM

DONEPEZIL HYDROCHLORIDE USP, NON-STERILE DRUG SUBSTANCE

DOXAZOSIN MESYLATE USP (NON-STERILE DRUG SUBSTANCE)

DRONEDARONE HYDROCHLORIDE USP

DULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DUTASTERIDE USP

Desmopressin

Dicloxacillin Sodium (BP/Ph. Eur)

Domperidone

Domperidone maleate

EFAVIRENZ USP

EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE)

ELETRIPTAN HYDROBROMIDE

EMPAGLIFLOZIN

EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE

ENTACAPONE USP (NON-STERILE DRUG SUBSTANCE)

ENTECAVIR

ERTAPENEM SODIUM

ESCITALOPRAM OXALATE USP

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II)

ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE)

EZETIMIBE USP

Entecavir monohydrate

Escitalopram Sodium (IH)

Esomperazole Magnesium Dihydrate (Ph. Fur)

FAMCICLOVIR USP

FEBUXOSTAT

FELODIPINE USP, NON-STERILE DRUG SUBSTANCE

FEXOFENADINE HYDROCHLORIDE USP

FINASTERIDE USP

FLECAINIDE ACETATE USP

FLUCONAZOLE USP

FLUOXETINE HYDROCHLORIDE USP

FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE)

FONDAPARINUX SODIUM

FOSAPREPITANT DIMEGLUMINE

FOSINOPRIL SODIUM USP

Finasteride EAA route

Flucloxacillin magnesium octahydrate

Flucloxacillin sodium

Flucloxacillin sodium Sterile

GABAPENTIN USP (NON-STERILE DRUG SUBSTANCE)

GALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE)

GANCICLOVIR USP

GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE)

GEIBROZIL USP

GLYBURIDE USP

GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE

Gabapentin Tributylamine route

HYDRALAZINE HYDROCHLORIDE USP

HYDROCHLOROTHIAZIDE USP

IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)

IMIPENEM USP (STERILE)

INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE)

IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE)

ISOPROTERENOL HYDROCHLORIDE

ISOSULFAN BLUE

Ibandronate Sodium

Irbesartan Ph.Eur

Iron Sucrose (IH)

LACOSAMIDE (NON-STERILE DRUG SUBSTANCE)

LAMIVUDINE USP

LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I)

LAMOTRIGINE USP (NON-STERILE DRUG SUBSTANCE)

LEUPROLIDE ACETATE USP

LEVETIRACETAM USP

LEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE)

LINACLOTIDE

LINAGLIPTIN

LISINOPRIL USP

LOPINAVIR (NON STERILE DRUG SUBSTANCE)

LORCASERIN HYDROCHLORIDE HEMIHYDRATE

LOSARTAN POTASSIUM USP DRUG SUBSTANCE

LURASIDONE HYDROCHLORIDE

Levofloxacin (1H)

Levofloxacin hydrate

Lisinopril dihydrate

MACITENTAN

MELOXICAM USP

MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

MEROPENEM FOR INJECTION (STERILE BULK)

METFORMIN HYDROCHLORIDE USP

METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE)

METOPROLOL SUCCINATE USP

METOPROLOL TARTRATE USP

MIRABEGRON

MIRTAZAPINE ANHYDROUS USP

MODAFINIL USP (NON-STERILE DRUG SUBSTANCE)

MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE)

MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

Metformin Hydrochloride (BP/Ph. Eur./USP)

Montelukast Sodium (Ph. Eur.)

NAFCILLIN FOR INJECTION USP (STERILE) BULK

NAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE

NAPROXEN USP (NON STERILE DRUG SUBSTANCE)

NELFINAVIR MESYLATE

NEVIRAPINE ANHYDROUS USP

Naproxen

Nateglinide (IH)

Sodium alendronate trihydrate

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Status - Active

Status - Inactive

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EXPIRED

SUSPENDED

VALID

WITHDRAWN BY HOLDER

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222MF10186

224MF10214

224MF10221

225MF10051

226MF10048

226MF10061

226MF10135

227MF10029

227MF10088

228MF10097

229MF10046

229MF10175

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WC-0017

WC-0023

WC-0120

WC-0121

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
6-AMINO PENICILLANIC ACID DRUG SUBS...
Issue/Submission Date
2006-03-31
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
6-AMINO PENICILLANIC ACID DRUG SUBS...
Issue/Submission Date
2006-03-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
6 AMINO PENICILLANIC ACID
Issue/Submission Date
2009-05-27
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
6 AMINO PENICILLANIC ACID
Issue/Submission Date
2009-05-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
7-AMINO DESACETOXY CEPHALOSPORANIC ...
Issue/Submission Date
2004-07-05
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
7-AMINO DESACETOXY CEPHALOSPORANIC ...
Issue/Submission Date
2004-07-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ABACAVIR SULFATE USP
Issue/Submission Date
2005-03-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Abacavir sulfate
Issue/Submission Date
2015-11-20
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0023
Status
Valid - 2019-06-05
Filing Details
Abacavir Sulfate Ph.Eur
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
ABACAVIR SULFATE USP
Abacavir sulfate
Abacavir Sulfate Ph.Eur
Issue/Submission Date
2005-03-24
2015-11-20
2016-07-14
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-0023
Status
Valid - 2019-06-05
Filing Details
Abacavir Sulfate
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
 
Valid - 2019-06-05
Filing Details
Abacavir Sulfate
Issue/Submission Date
2016-08-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALENDRONATE SODIUM USP (NON-STERILE...
Issue/Submission Date
2006-12-04
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
Indian CDSCO WC-0023
Status
Valid - 2019-06-05
Filing Details
Alendronate Sodium (Ph.Eur)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
ALENDRONATE SODIUM USP (NON-STERILE...
Alendronate Sodium (Ph.Eur)
Issue/Submission Date
2006-12-04
2016-07-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALFUZOSIN HYDROCHLORIDE USP (NON-ST...
Issue/Submission Date
2007-02-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alfuzosin hydrochloride
Issue/Submission Date
2017-09-25
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Alfuzosin Hydrochloride Ph. Eur.
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-05-27
Filing Details
ALFUZOSIN HYDROCHLORIDE USP (NON-ST...
Alfuzosin hydrochloride
Alfuzosin Hydrochloride Ph. Eur.
Issue/Submission Date
2007-02-24
2017-09-25
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMIODARONE HYDROCHLORIDE
Issue/Submission Date
2004-03-05
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
AMIODARONE HYDROCHLORIDE
Issue/Submission Date
2004-03-05
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
Amisulpride
Issue/Submission Date
2018-07-24
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0120
Status
Valid - 2019-07-02
Filing Details
Amisulpride (EP)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
VALID
 
Valid - 2019-07-02
Filing Details
Amisulpride
Amisulpride (EP)
Issue/Submission Date
2018-07-24
2016-07-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMLODIPINE BESYLATE USP
Issue/Submission Date
2005-11-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amlodipine besilate
Issue/Submission Date
2017-12-19
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Amlodipine besylate at Plot No. 2, ...
Issue/Submission Date
2014-03-06
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Amlodipine Besilate (Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-05-27
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine besilate
Amlodipine besylate at Plot No. 2, ...
Amlodipine Besilate (Ph.Eur.)
Issue/Submission Date
2005-11-09
2017-12-19
2014-03-06
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMOXICILLIN USP
Issue/Submission Date
2005-08-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amoxicillin sodium Sterile
Issue/Submission Date
2017-06-02
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
VALID
 
Filing Details
AMOXICILLIN USP
Amoxicillin sodium Sterile
Issue/Submission Date
2005-08-31
2017-06-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMOXICILLIN SODIUM (STERILE) BULK
Issue/Submission Date
2006-12-30
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
AMOXICILLIN SODIUM (STERILE) BULK
Issue/Submission Date
2006-12-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMOXICILLIN USP (ENZYME ROUTE)
Issue/Submission Date
2017-01-10
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 - Paid
DMF Review - Complete
 
Filing Details
AMOXICILLIN USP (ENZYME ROUTE)
Issue/Submission Date
2017-01-10
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-0121
Status
Valid - 2019-07-02
Filing Details
Amoxicillin Sodium (Sterile) (BP/Ph...
Issue/Submission Date
2016-09-21
Supporting Info
Application Number
Indian CDSCO WC-0121
Status
 
Valid - 2019-07-02
Filing Details
Amoxicillin Sodium (Sterile) (BP/Ph...
Issue/Submission Date
2016-09-21
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
Amoxicillin trihydrate Enzymatic pr...
Issue/Submission Date
2017-12-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0023
Status
Valid - 2019-06-05
Filing Details
Amoxicillin Trihydrate (Ph. Eur)
Issue/Submission Date
2017-01-06
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
VALID
 
Valid - 2019-06-05
Filing Details
Amoxicillin trihydrate Enzymatic pr...
Amoxicillin Trihydrate (Ph. Eur)
Issue/Submission Date
2017-12-06
2017-01-06
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
Amoxicillin trihydrate
Issue/Submission Date
2017-10-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0023
Status
Valid - 2019-06-05
Filing Details
Amoxicillin Trihdrate
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
VALID
 
Valid - 2019-06-05
Filing Details
Amoxicillin trihydrate
Amoxicillin Trihdrate
Issue/Submission Date
2017-10-03
2016-08-22
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-0121
Status
Valid - 2019-07-02
Filing Details
Amoxicillin Trihydrate (Ph. Eur)
Issue/Submission Date
2016-09-21
Supporting Info
Application Number
Indian CDSCO WC-0121
Status
 
Valid - 2019-07-02
Filing Details
Amoxicillin Trihydrate (Ph. Eur)
Issue/Submission Date
2016-09-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPICILLIN AND SULBACTAM FOR INJECT...
Issue/Submission Date
2007-02-22
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 - N/A
 
Filing Details
AMPICILLIN AND SULBACTAM FOR INJECT...
Issue/Submission Date
2007-02-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMPICILLIN SODIUM USP (STERILE) BUL...
Issue/Submission Date
2007-01-16
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ampicillin sodium Sterile
Issue/Submission Date
2017-10-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0121
Status
Valid - 2019-07-02
Filing Details
Ampicillin Sodium Sterile (Ph. Eur)
Issue/Submission Date
2016-09-21
Supporting Info
Application Number
Indian CDSCO WC-0121
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
AMPICILLIN SODIUM USP (STERILE) BUL...
Ampicillin sodium Sterile
Ampicillin Sodium Sterile (Ph. Eur)
Issue/Submission Date
2007-01-16
2017-10-03
2016-09-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPICILLIN TRIHYDRATE, USP
Issue/Submission Date
2006-02-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ampicillin trihydrate
Issue/Submission Date
2017-10-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0121
Status
Valid - 2019-07-02
Filing Details
Ampicillin Trihydrate (BP/Ph. Eur)
Issue/Submission Date
2016-09-21
Supporting Info
Application Number
Indian CDSCO WC-0121
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
AMPICILLIN TRIHYDRATE, USP
Ampicillin trihydrate
Ampicillin Trihydrate (BP/Ph. Eur)
Issue/Submission Date
2006-02-28
2017-10-03
2016-09-21
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APIXABAN
Issue/Submission Date
2016-07-12
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 - Paid
DMF Review - Complete
 
Filing Details
APIXABAN
Issue/Submission Date
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST
Issue/Submission Date
2017-10-06
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
Issue/Submission Date
2017-10-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ARIPIPRAZOLE USP (NON-STERILE DRUG ...
Issue/Submission Date
2011-06-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Aripiprazole
Issue/Submission Date
2017-12-13
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0120
Status
Valid - 2019-07-02
Filing Details
Aripiprazole (IH)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ARIPIPRAZOLE USP (NON-STERILE DRUG ...
Aripiprazole
Aripiprazole (IH)
Issue/Submission Date
2011-06-07
2017-12-13
2016-07-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ARMODAFINIL
Issue/Submission Date
2013-07-29
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ARMODAFINIL
Issue/Submission Date
2013-07-29
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATAZANAVIR SULFATE (NON-STERILE DRU...
Issue/Submission Date
2011-12-06
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-0017
Status
Valid - 2019-05-27
Filing Details
Atazanavir Sulfate(IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-05-27
Filing Details
ATAZANAVIR SULFATE (NON-STERILE DRU...
Atazanavir Sulfate(IH)
Issue/Submission Date
2011-12-06
2016-07-12
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
2007-03-16
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Atomoxetine hydrochloride
Issue/Submission Date
2016-02-11
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0023
Status
Valid - 2019-06-05
Filing Details
Atomoxetine Hydrochloride (IH
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-06-05
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Atomoxetine hydrochloride
Atomoxetine Hydrochloride (IH
Issue/Submission Date
2007-03-16
2016-02-11
2016-07-14
Supporting Info
See all info for this product

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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-0023
Status
Valid - 2019-06-05
Filing Details
Atomoxetine Hydrochloride
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
 
Valid - 2019-06-05
Filing Details
Atomoxetine Hydrochloride
Issue/Submission Date
2016-08-22
Supporting Info
See all info for this product

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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-0023
Status
Valid - 2019-06-05
Filing Details
Atomoxetine Hydrochloride (Ph. Eur)
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0023
Status
 
Valid - 2019-06-05
Filing Details
Atomoxetine Hydrochloride (Ph. Eur)
Issue/Submission Date
2016-08-22
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM (AMORPHOUS)
Issue/Submission Date
2010-09-27
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 - N/A
 
Filing Details
ATORVASTATIN CALCIUM (AMORPHOUS)
Issue/Submission Date
2010-09-27
Supporting Info
See all info for this product

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USDMF

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

Application Number
Status
VALID
Filing Details
Atorvastatin calcium trihydrate
Issue/Submission Date
2017-09-29
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia atorvastatin...
Issue/Submission Date
2014-02-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Atorvastatin calcium trihydrate
Japanese Pharmacopoeia atorvastatin...
Issue/Submission Date
2017-09-29
2014-02-20
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATOVAQUONE USP
Issue/Submission Date
2017-04-25
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 - Paid
DMF Review - Complete
 
Filing Details
ATOVAQUONE USP
Issue/Submission Date
2017-04-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Issue/Submission Date
2005-11-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Benazepril hydrochloride
Issue/Submission Date
2017-12-19
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Benazepril Hydrochloride (Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-05-27
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Benazepril hydrochloride
Benazepril Hydrochloride (Ph.Eur.)
Issue/Submission Date
2005-11-28
2017-12-19
2016-07-12
Supporting Info
See all info for this product

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USDMF

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

Application Number
Status
VALID
Filing Details
Betahistine dihydrochloride
Issue/Submission Date
2017-10-16
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Betahistine Dihydrochloride (Ph.Eur...
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
VALID
 
Valid - 2019-05-27
Filing Details
Betahistine dihydrochloride
Betahistine Dihydrochloride (Ph.Eur...
Issue/Submission Date
2017-10-16
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BISOPROLOL FUMARATE USP
Issue/Submission Date
2005-09-12
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bisoprolol fumarate
Issue/Submission Date
2018-04-20
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0120
Status
Valid - 2019-07-02
Filing Details
Bisoprolol Fumarate (Ph. Eur./USP)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
BISOPROLOL FUMARATE USP
Bisoprolol fumarate
Bisoprolol Fumarate (Ph. Eur./USP)
Issue/Submission Date
2005-09-12
2018-04-20
2016-07-14
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BOSENTAN MONOHYDRATE (NON-STERILE D...
Issue/Submission Date
2013-02-14
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
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Bosentan Monohydrate (IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-05-27
Filing Details
BOSENTAN MONOHYDRATE (NON-STERILE D...
Bosentan Monohydrate (IH)
Issue/Submission Date
2013-02-14
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BUPROPION HYDROCHLORIDE USP
Issue/Submission Date
2006-01-30
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 - N/A
 
Filing Details
BUPROPION HYDROCHLORIDE USP
Issue/Submission Date
2006-01-30
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-09-28
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
CANAGLIFLOZIN
Issue/Submission Date
2016-09-28
Supporting Info
See all info for this product

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USDMF

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

Application Number
Status
VALID
Filing Details
Candesartan cilexetil Process-2
Issue/Submission Date
2017-12-18
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
Candesartan cilexetil Process-2
Issue/Submission Date
2017-12-18
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CANDESARTAN CILEXETIL (NON STERILE ...
Issue/Submission Date
2010-11-04
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Candesartan cilexetil
Issue/Submission Date
2017-12-18
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0120
Status
Valid - 2019-07-02
Filing Details
Candesartan Cilexetil (IH)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
WITHDRAWN BY HOLDER
 
Valid - 2019-07-02
Filing Details
CANDESARTAN CILEXETIL (NON STERILE ...
Candesartan cilexetil
Candesartan Cilexetil (IH)
Issue/Submission Date
2010-11-04
2017-12-18
2016-07-14
Supporting Info
See all info for this product

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USDMF

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

Application Number
Status
VALID
Filing Details
Carbimazole
Issue/Submission Date
2018-04-05
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
Carbimazole
Issue/Submission Date
2018-04-05
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARISOPRODOL USP
Issue/Submission Date
2006-04-18
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CARISOPRODOL USP
Issue/Submission Date
2006-04-18
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARMUSTINE USP
Issue/Submission Date
2017-12-26
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CARMUSTINE USP
Issue/Submission Date
2017-12-26
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARVEDILOL USP
Issue/Submission Date
2006-01-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carvedilol
Issue/Submission Date
2017-12-19
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0017
Status
Valid - 2019-05-27
Filing Details
Carvedilol (Ph. Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0017
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-05-27
Filing Details
CARVEDILOL USP
Carvedilol
Carvedilol (Ph. Eur.)
Issue/Submission Date
2006-01-06
2017-12-19
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CEFACLOR USP
Issue/Submission Date
2006-07-26
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CEFACLOR USP
Issue/Submission Date
2006-07-26
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CEFADROXIL USP
Issue/Submission Date
2005-04-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cefadroxil monohydrate
Issue/Submission Date
2017-12-13
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0120
Status
Valid - 2019-07-02
Filing Details
Cefadroxil Monohydrate (BP/EP/USP)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CEFADROXIL USP
Cefadroxil monohydrate
Cefadroxil Monohydrate (BP/EP/USP)
Issue/Submission Date
2005-04-30
2017-12-13
2016-07-14
Supporting Info
See all info for this product

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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-0120
Status
Valid - 2019-07-02
Filing Details
Cefalexin (BP/EP/USP)
Issue/Submission Date
2016-07-14
Supporting Info
Application Number
Indian CDSCO WC-0120
Status
 
Valid - 2019-07-02
Filing Details
Cefalexin (BP/EP/USP)
Issue/Submission Date
2016-07-14
Supporting Info
See all info for this product

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