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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Emcure Pharmaceuticals Limited

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(S)- METHYL-3- (4-BIS(2-HYDROXYETHYL) AMINO) PHENYL) -2 - (TERT- BUTOXYCARBONYLAMINO) PROPANOATE

4'-ACETYLOXY 2, 4-DIFLUOROBIPHENYL

ACAMPROSATE CALCIUM

ACETAZOLAMIDE USP

ANASTROZOLE USP

ARGATROBAN USP

ATAZANAVIR SULFATE

BENDAMUSTINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

BEXAROTENE

BICALUTAMIDE USP

BUSULFAN USP

CARMUSTINE USP

CIDOFOVIR USP

CLOFARABINE

COLESEVELAM HYDROCHLORIDE

CYCLOPHOSPHAMIDE USP

DARIFENACIN HYDROBROMIDE

DECITABINE MONOHYDRATE

DEFERIPRONE

DEXMEDETOMIDINE HYDROCHLORIDE USP

DOCETAXEL TRIHYDRATE USP (PROCESS II)

DOCETAXEL USP

DOFETILIDE USP

DOLASETRON MESYLATE USP

DRONEDARONE HYDROCHLORIDE

Dexketoprofen Trometamo! (IH)

EFAVIRENZ (ALTERNATE PROCESS)

EFAVIRENZ USP

EMTRICITABINE

ENOXAPARIN SODIUM USP

EPL 001

ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE SODIUM (PROCESS II)

ESZOPICLONE

ETODOLAC USP

FEBUXOSTAT

FELBAMATE USP

FELODIPINE USP

FENOPROFEN CALCIUM USP

FINGOLIMOD HYDROCHLORIDE

FLECAINIDE ACETATE USP

GEMCITABINE HYDROCHLORIDE USP

GEMCITABINE HYDROCHLORIDE USP (PROCESS II)

IBANDRONATE SODIUM MONOHYDRATE

IBUTILIDE FUMARATE USP

IRINOTECAN HYDROCHLORIDE USP

IRON SUCROSE COMPLEX SOLUTION

ISOPROTERENOL HYDROCHLORIDE USP

KETOROLAC TROMETHAMINE USP

LEFLUNOMIDE USP

MEFLOQUINE HYDROCHLORIDE USP

MELPHALAN HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE USP

MIDODRINE HYDROCHLORIDE USP

MILRINONE USP

MYCOPHENOLATE MOFETIL USP

NEOSTIGMINE METHYLSULFATE USP

NISOLDIPINE

OLSALAZINE SODIUM

OLSALAZINE SODIUM (PROCESS II)

OXALIPLATIN USP

PALIPERIDONE USP

PALONOSETRON HYDROCHLORIDE USP

PANTOPRAZOLE SODIUM USP

PEMETREXED DISODIUM HEMIPENTAHYDRATE

PERPHENAZINE USP

PHYTONADIONE USP

PROCHLORPERAZINE EDISYLATE USP

PROMETHAZINE HYDROCHLORIDE USP

PROPAFENONE HYDROCHLORIDE USP

PROPOFOL USP

PROTRIPTYLINE HYDROCHLORIDE USP

RALTEGRAVIR POTASSIUM

RITONAVIR USP

RITONAVIR USP (PROCESS II)

RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE USP

ROPIVACAINE HYDROCHLORIDE USP (PROCESS II)

SEVELAMER CARBONATE (E SUB)

SEVELAMER CARBONATE (FOR POWDER FORMULATION)

SEVELAMER CARBONATE (PROCESS II)

SEVELAMER HYDROCHLORIDE (PROCESS II)

SEVELAMER HYDROCHLORIDE (PROCESS-I)

SM ARG-I

SODIUM CARBONATE MONOHYDRATE USP-NF

SODIUM FERRIC GLUCONATE COMPLEX

SODIUM NITROPRUSSIDE USP

SULFAMETHOXAZOLE USP

TENOFOVIR ALAFENAMIDE FUMARATE

TENOFOVIR DISOPROXIL FUMARATE

TERIFLUNOMIDE

THIAMINE HYDROCHLORIDE USP

TOLTERODINE TARTRATE

TOPOTECAN HYDROCHLORIDE

TRIENTINE HYDROCHLORIDE USP

TRIMETHOBENZAMIDE HYDROCHLORIDE USP

ZILEUTON USP

ZOLEDRONIC ACID

ZOLMITRIPTAN

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Status - Active

Status - Inactive

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VALID

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WC-0226

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACAMPROSATE CALCIUM
Issue/Submission Date
2012-03-30
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
ACAMPROSATE CALCIUM
Issue/Submission Date
2012-03-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACETAZOLAMIDE USP
Issue/Submission Date
2007-02-23
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
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Acetazolamide (USP/Ph.Eur)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
ACETAZOLAMIDE USP
Acetazolamide (USP/Ph.Eur)
Issue/Submission Date
2007-02-23
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ANASTROZOLE USP
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ANASTROZOLE USP
Issue/Submission Date
2011-12-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARGATROBAN USP
Issue/Submission Date
2012-03-19
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
ARGATROBAN USP
Issue/Submission Date
2012-03-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATAZANAVIR SULFATE
Issue/Submission Date
2006-12-06
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ATAZANAVIR SULFATE
Issue/Submission Date
2006-12-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BENDAMUSTINE HYDROCHLORIDE
Issue/Submission Date
2012-03-31
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
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Bendamustine Hydrochloride (IH)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
BENDAMUSTINE HYDROCHLORIDE
Bendamustine Hydrochloride (IH)
Issue/Submission Date
2012-03-31
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENZPHETAMINE HYDROCHLORIDE
Issue/Submission Date
2010-07-06
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 - N/A
 
Filing Details
BENZPHETAMINE HYDROCHLORIDE
Issue/Submission Date
2010-07-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BEXAROTENE
Issue/Submission Date
2017-10-03
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 - Paid
DMF Review - N/A
 
Filing Details
BEXAROTENE
Issue/Submission Date
2017-10-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BICALUTAMIDE USP
Issue/Submission Date
2011-06-08
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
BICALUTAMIDE USP
Issue/Submission Date
2011-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUSULFAN USP
Issue/Submission Date
2011-12-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Busulfan
Issue/Submission Date
2017-06-21
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Busulfan (USP)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
BUSULFAN USP
Busulfan
Busulfan (USP)
Issue/Submission Date
2011-12-29
2017-06-21
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARMUSTINE USP
Issue/Submission Date
2009-06-22
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carmustine
Issue/Submission Date
2016-11-30
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
CARMUSTINE USP
Carmustine
Issue/Submission Date
2009-06-22
2016-11-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIDOFOVIR USP
Issue/Submission Date
2010-11-30
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
CIDOFOVIR USP
Issue/Submission Date
2010-11-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOFARABINE
Issue/Submission Date
2013-12-30
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CLOFARABINE
Issue/Submission Date
2013-12-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
COLESEVELAM HYDROCHLORIDE
Issue/Submission Date
2013-03-31
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
COLESEVELAM HYDROCHLORIDE
Issue/Submission Date
2013-03-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYCLOPHOSPHAMIDE USP
Issue/Submission Date
2009-05-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cyclophosphamide
Issue/Submission Date
2019-03-05
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Cyclophosphamide (USP)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CYCLOPHOSPHAMIDE USP
Cyclophosphamide
Cyclophosphamide (USP)
Issue/Submission Date
2009-05-21
2019-03-05
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CYCLOPHOSPHAMIDE USP
Issue/Submission Date
2015-09-30
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
CYCLOPHOSPHAMIDE USP
Issue/Submission Date
2015-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DARIFENACIN HYDROBROMIDE
Issue/Submission Date
2013-02-15
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
DARIFENACIN HYDROBROMIDE
Issue/Submission Date
2013-02-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DECITABINE MONOHYDRATE
Issue/Submission Date
2013-03-29
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
DECITABINE MONOHYDRATE
Issue/Submission Date
2013-03-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFERIPRONE
Issue/Submission Date
2008-05-19
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
DEFERIPRONE
Issue/Submission Date
2008-05-19
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-0226
Status
Valid - 2019-07-02
Filing Details
Dexketoprofen Trometamo! (IH)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
 
Valid - 2019-07-02
Filing Details
Dexketoprofen Trometamo! (IH)
Issue/Submission Date
2016-08-10
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
DEXMEDETOMIDINE HYDROCHLORIDE USP
Issue/Submission Date
2014-03-18
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 - Complete
 
Filing Details
DEXMEDETOMIDINE HYDROCHLORIDE USP
Issue/Submission Date
2014-03-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
SODIUM CARBONATE MONOHYDRATE USP-NF
Issue/Submission Date
2017-04-24
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
SODIUM CARBONATE MONOHYDRATE USP-NF
Issue/Submission Date
2017-04-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOCETAXEL USP
Issue/Submission Date
2012-03-27
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DOCETAXEL USP
Issue/Submission Date
2012-03-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DOCETAXEL TRIHYDRATE USP (PROCESS I...
Issue/Submission Date
2014-01-10
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
DOCETAXEL TRIHYDRATE USP (PROCESS I...
Issue/Submission Date
2014-01-10
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
DOFETILIDE USP
Issue/Submission Date
2017-08-10
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
DOFETILIDE USP
Issue/Submission Date
2017-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOLASETRON MESYLATE USP
Issue/Submission Date
2011-03-28
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 - N/A
 
Filing Details
DOLASETRON MESYLATE USP
Issue/Submission Date
2011-03-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-06-29
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 - N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-06-29
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EFAVIRENZ 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
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
EFAVIRENZ USP
Issue/Submission Date
2007-01-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EFAVIRENZ (ALTERNATE PROCESS)
Issue/Submission Date
2009-04-07
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
EFAVIRENZ (ALTERNATE PROCESS)
Issue/Submission Date
2009-04-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EMTRICITABINE
Issue/Submission Date
2009-10-16
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
EMTRICITABINE
Issue/Submission Date
2009-10-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ENOXAPARIN SODIUM USP
Issue/Submission Date
2013-03-31
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ENOXAPARIN SODIUM USP
Issue/Submission Date
2013-03-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESOMEPRAZOLE SODIUM
Issue/Submission Date
2011-07-30
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
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Esomeprazole Sodium (IH)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ESOMEPRAZOLE SODIUM
Esomeprazole Sodium (IH)
Issue/Submission Date
2011-07-30
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESOMEPRAZOLE SODIUM (PROCESS II)
Issue/Submission Date
2013-08-22
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
ESOMEPRAZOLE SODIUM (PROCESS II)
Issue/Submission Date
2013-08-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESZOPICLONE
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-0226
Status
Valid - 2019-07-02
Filing Details
Eszopiclone (IH)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ESZOPICLONE
Eszopiclone (IH)
Issue/Submission Date
2011-02-21
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ETODOLAC USP
Issue/Submission Date
2012-03-27
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
ETODOLAC USP
Issue/Submission Date
2012-03-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FEBUXOSTAT
Issue/Submission Date
2013-02-01
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
FEBUXOSTAT
Issue/Submission Date
2013-02-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FELBAMATE USP
Issue/Submission Date
2015-06-26
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
FELBAMATE USP
Issue/Submission Date
2015-06-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FELODIPINE USP
Issue/Submission Date
2011-02-25
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
FELODIPINE USP
Issue/Submission Date
2011-02-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FENOPROFEN CALCIUM USP
Issue/Submission Date
2008-10-22
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
FENOPROFEN CALCIUM USP
Issue/Submission Date
2008-10-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-06-19
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
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-06-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FLECAINIDE ACETATE USP
Issue/Submission Date
2014-01-28
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
FLECAINIDE ACETATE USP
Issue/Submission Date
2014-01-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2009-12-04
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-0226
Status
Valid - 2019-07-02
Filing Details
Gemcitabine Hydrochloride (USP)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine Hydrochloride (USP)
Issue/Submission Date
2009-12-04
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GEMCITABINE HYDROCHLORIDE USP (PROC...
Issue/Submission Date
2013-10-25
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
GEMCITABINE HYDROCHLORIDE USP (PROC...
Issue/Submission Date
2013-10-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IBANDRONATE SODIUM MONOHYDRATE
Issue/Submission Date
2011-09-09
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IBANDRONATE SODIUM MONOHYDRATE
Issue/Submission Date
2011-09-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IBUTILIDE FUMARATE USP
Issue/Submission Date
2012-03-19
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
IBUTILIDE FUMARATE USP
Issue/Submission Date
2012-03-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IRINOTECAN HYDROCHLORIDE USP
Issue/Submission Date
2009-10-27
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
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Irinotecan Hydrochloride (USP)
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
IRINOTECAN HYDROCHLORIDE USP
Irinotecan Hydrochloride (USP)
Issue/Submission Date
2009-10-27
2016-08-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
IRON SUCROSE COMPLEX SOLUTION
Issue/Submission Date
2014-05-30
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
IRON SUCROSE COMPLEX SOLUTION
Issue/Submission Date
2014-05-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ISOPROTERENOL HYDROCHLORIDE USP
Issue/Submission Date
2017-10-18
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 - Complete
 
Filing Details
ISOPROTERENOL HYDROCHLORIDE USP
Issue/Submission Date
2017-10-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
KETOROLAC TROMETHAMINE USP
Issue/Submission Date
2015-09-30
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
KETOROLAC TROMETHAMINE USP
Issue/Submission Date
2015-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LEFLUNOMIDE USP
Issue/Submission Date
2002-09-06
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 - N/A
 
Filing Details
LEFLUNOMIDE USP
Issue/Submission Date
2002-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MEFLOQUINE HYDROCHLORIDE USP
Issue/Submission Date
2008-10-23
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
Indian CDSCO WC-0226
Status
Valid - 2019-07-02
Filing Details
Mefloquine Hydrochloride (USP/BP/Ph...
Issue/Submission Date
2016-08-10
Supporting Info
Application Number
Indian CDSCO WC-0226
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A