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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apotex Pharmachem Inc.

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ADEFOVIR DIPIVOXIL

ALFUZOSIN HYDROCHLORIDE USP

ALMOTRIPTAN MALATE

ALPRAZOLAM USP

ANASTROZOLE USP

APIXABAN

ARIPIPRAZOLE USP

ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM GRANULATION

BICALUTAMIDE USP

BUDESONIDE USP

BUSPIRONE HYDROCHLORIDE

CABERGOLINE USP

CANDESARTAN CILEXETIL USP

CAPECITABINE USP

CARVEDILOL DIHYDROGEN PHOSPHATE

CEVIMELINE HYDROCHLORIDE HEMIHYDRATE

CIMETIDINE

CLONAZEPAM USP

CYCLOSPORINE USP (BULK)

CYTARABINE USP XXI

DABIGATRAN ETEXILATE MESYLATE

DARIFENACIN HYDROBROMIDE

DEFERASIROX

DEFERIPRONE(L1)

DESVENLAFAXINE SUCCINATE MONOHYDRATE

DEXLANSOPRAZOLE ANHYDRATE

DOLASETRON MESYLATE MONOHYDRATE USP

DONEPEZIL HYDROCHLORIDE MONOHYDRRATE USP

DOXAZOSIN MESYLATE USP

DRONEDARONE HYDROCHLORIDE

ELETRIPTAN HYDROBROMIDE

ELIGLUSTAT TARTRATE

ENALAPRIL MALEATE USP

ENTECAVIR USP

EPLERENONE MEK HEMISOLVATE (1:0.5)

ERLOTINIB HYDROCHLORIDE

ESZOPICLONE USP

ETRAVIRINE

EXEMESTANE

FAMOTIDINE USP

FEBUXOSTAT

FESOTERODINE FUMARATE

FINGOLIMOD HYDROCHLORIDE

FLUVOXAMINE MALEATE USP

GAMMA-HYDROXYBUTYRATE

GATIFLOXACIN HEMIHYDRATE

IBANDRONATE SODIUM

LAMOTRIGINE

LANSOPRAZOLE USP

LETROZOLE USP

LEVOFLOXACIN USP

LEVOTHYROXINE SODIUM USP

LINEZOLID

LUBIPROSTONE

LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE USP

METHACHOLINE CHLORIDE USP

MIDODRINE HYDROCHLORIDE USP

MISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC)

MOEXIPRIL HYDROCHLORIDE USP

MONTELUKAST SODIUM USP

MYCOPHENOLATE MOFETIL USP

MYCOPHENOLATE SODIUM

NARATRIPTAN HYDROCHLORIDE USP

OLANZAPINE USP

OLMESARTAN MEDOXOMIL USP

OLOPATADINE HYDROCHLORIDE USP

PALBOCICLIB

PALIPERIDONE USP

PAMIDRONIC ACID

PAROXETINE HYDROCHLORIDE (ANHYDROUS)

PAROXETINE HYDROCHLORIDE ANHYDROUS USP

PERINDOPRIL ARGININE

PERINDOPRIL TERT-BUTYLAMINE

POSACONAZOLE

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM

RALOXIFENE HYDROCHLORIDE USP

RAMIPRIL USP

RANITIDINE HCL USP

RANOLAZINE

RASAGILINE MESYLATE

RILUZOLE USP

RISEDRONATE SODIUM HEMIPENTAHYDRATE USP

RISPERIDONE USP

RIVAROXABAN

RIVASTIGMINE TARTRATE

RIVASTIGMINE USP

RIZATRIPTAN BENZOATE USP

ROSUVASTATIN CALCIUM

RUFINAMIDE USP

SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20%

SITAGLIPTIN PHOSPHATE MONOHYDRATE USP

SUMATRIPTAN SUCCINATE USP

TADALAFIL USP

TASIMELTEON

TERAZOSIN HCI DIHYDRATE

TETRABENAZINE

TIZANIDINE HYDROCHLORIDE USP

TOFACITINIB CITRATE

TOLTERODINE TARTRATE

TOLVAPTAN

TORSEMIDE USP

TREPROSTINIL DIETHANOLAMINE

TROSPIUM CHLORIDE USP

VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP

VALGANCICLOVIR HYDROCHLORIDE USP

VARENICLINE TARTRATE

VENLAFAXINE HYDROCHLORIDE USP

VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE

VORICONAZOLE USP

WARFARIN POTASSIUM ISOPROPANOL SOLVATE

WARFARIN SODIUM CLATHRATE USP

ZALEPLON

ZIPRASIDONE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

ZOLMITRIPTAN

ZONISAMIDE

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Status - Active

Status - Inactive

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EXPIRED

VALID

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WC-0128

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ADEFOVIR DIPIVOXIL
Issue/Submission Date
2012-12-07
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ADEFOVIR DIPIVOXIL
Issue/Submission Date
2012-12-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALFUZOSIN HYDROCHLORIDE USP
Issue/Submission Date
2007-06-08
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ALFUZOSIN HYDROCHLORIDE USP
Issue/Submission Date
2007-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALMOTRIPTAN MALATE
Issue/Submission Date
2011-08-16
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
ALMOTRIPTAN MALATE
Issue/Submission Date
2011-08-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALPRAZOLAM USP
Issue/Submission Date
2011-06-24
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
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
Alprazolam (USP)
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-07-02
Filing Details
ALPRAZOLAM USP
Alprazolam (USP)
Issue/Submission Date
2011-06-24
2014-03-06
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
2009-12-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Anastrozole
Issue/Submission Date
2016-01-15
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
VALID
 
Filing Details
ANASTROZOLE USP
Anastrozole
Issue/Submission Date
2009-12-01
2016-01-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APIXABAN
Issue/Submission Date
2016-06-20
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
2016-06-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2006-11-13
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
ARIPIPRAZOLE USP
Issue/Submission Date
2006-11-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATOMOXETINE HYDROCHLORIDE
Issue/Submission Date
2007-05-18
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
ATOMOXETINE HYDROCHLORIDE
Issue/Submission Date
2007-05-18
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM GRANULATION
Issue/Submission Date
2006-12-15
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATORVASTATIN CALCIUM GRANULATION
Issue/Submission Date
2006-12-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BICALUTAMIDE USP
Issue/Submission Date
2009-05-15
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 - N/A
 
Filing Details
BICALUTAMIDE USP
Issue/Submission Date
2009-05-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUDESONIDE USP
Issue/Submission Date
2013-11-01
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
BUDESONIDE USP
Issue/Submission Date
2013-11-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1991-01-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1991-01-11
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CABERGOLINE USP
Issue/Submission Date
2009-03-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cabergoline
Issue/Submission Date
2014-06-30
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
Cabergoline (USP/EP)
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Expired - 2016-07-02
Filing Details
CABERGOLINE USP
Cabergoline
Cabergoline (USP/EP)
Issue/Submission Date
2009-03-13
2014-06-30
2014-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CABERGOLINE USP
Issue/Submission Date
2012-07-13
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
CABERGOLINE USP
Issue/Submission Date
2012-07-13
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CANDESARTAN CILEXETIL USP
Issue/Submission Date
2010-07-02
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CANDESARTAN CILEXETIL USP
Issue/Submission Date
2010-07-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CAPECITABINE USP
Issue/Submission Date
2012-01-19
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
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
Capecitabine (USP)Dabigatran Etexil...
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-07-02
Filing Details
CAPECITABINE USP
Capecitabine (USP)Dabigatran Etexil...
Issue/Submission Date
2012-01-19
2014-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARVEDILOL DIHYDROGEN PHOSPHATE
Issue/Submission Date
2016-01-12
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CARVEDILOL DIHYDROGEN PHOSPHATE
Issue/Submission Date
2016-01-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
Issue/Submission Date
2009-02-06
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
CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
Issue/Submission Date
2009-02-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CIMETIDINE
Issue/Submission Date
1989-04-20
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
CIMETIDINE
Issue/Submission Date
1989-04-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLONAZEPAM USP
Issue/Submission Date
2008-11-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CLONAZEPAM USP
Issue/Submission Date
2008-11-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CYCLOSPORINE USP (BULK)
Issue/Submission Date
1999-01-04
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CYCLOSPORINE USP (BULK)
Issue/Submission Date
1999-01-04
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYTARABINE USP XXI
Issue/Submission Date
1988-03-04
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CYTARABINE USP XXI
Issue/Submission Date
1988-03-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DABIGATRAN ETEXILATE MESYLATE
Issue/Submission Date
2014-03-28
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 - Complete
 
Filing Details
DABIGATRAN ETEXILATE MESYLATE
Issue/Submission Date
2014-03-28
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
2013-08-23
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DARIFENACIN HYDROBROMIDE
Issue/Submission Date
2013-08-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFERASIROX
Issue/Submission Date
2014-06-30
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
DEFERASIROX
Issue/Submission Date
2014-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFERIPRONE(L1)
Issue/Submission Date
1994-04-12
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 - N/A
 
Filing Details
DEFERIPRONE(L1)
Issue/Submission Date
1994-04-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DESVENLAFAXINE SUCCINATE MONOHYDRAT...
Issue/Submission Date
2012-02-13
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
DESVENLAFAXINE SUCCINATE MONOHYDRAT...
Issue/Submission Date
2012-02-13
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXLANSOPRAZOLE ANHYDRATE
Issue/Submission Date
2015-03-30
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
DEXLANSOPRAZOLE ANHYDRATE
Issue/Submission Date
2015-03-30
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOLASETRON MESYLATE MONOHYDRATE USP
Issue/Submission Date
2011-01-06
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
DOLASETRON MESYLATE MONOHYDRATE USP
Issue/Submission Date
2011-01-06
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DONEPEZIL HYDROCHLORIDE MONOHYDRRAT...
Issue/Submission Date
2009-08-04
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DONEPEZIL HYDROCHLORIDE MONOHYDRRAT...
Issue/Submission Date
2009-08-04
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOXAZOSIN MESYLATE USP
Issue/Submission Date
1998-06-22
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DOXAZOSIN MESYLATE USP
Issue/Submission Date
1998-06-22
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-05-08
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
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-05-08
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ELETRIPTAN HYDROBROMIDE
Issue/Submission Date
2010-03-25
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
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
 Eletriptan Hydrobromide
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-07-02
Filing Details
ELETRIPTAN HYDROBROMIDE
 Eletriptan Hydrobromide
Issue/Submission Date
2010-03-25
2014-03-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ELIGLUSTAT TARTRATE
Issue/Submission Date
2018-05-01
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
ELIGLUSTAT TARTRATE
Issue/Submission Date
2018-05-01
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENALAPRIL MALEATE USP
Issue/Submission Date
2005-12-21
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-0128
Status
Expired - 2016-07-02
Filing Details
Enalapril Maleate (USP/EP) 
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-07-02
Filing Details
ENALAPRIL MALEATE USP
Enalapril Maleate (USP/EP) 
Issue/Submission Date
2005-12-21
2014-03-06
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENTECAVIR USP
Issue/Submission Date
2010-10-19
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
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
Entecavir 
Issue/Submission Date
2014-03-06
Supporting Info
Application Number
Indian CDSCO WC-0128
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Expired - 2016-07-02
Filing Details
ENTECAVIR USP
Entecavir 
Issue/Submission Date
2010-10-19
2014-03-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EPLERENONE MEK HEMISOLVATE (1:0.5)
Issue/Submission Date
2006-09-25
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
EPLERENONE MEK HEMISOLVATE (1:0.5)
Issue/Submission Date
2006-09-25
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2013-01-22
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
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2013-01-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESZOPICLONE USP
Issue/Submission Date
2013-02-13
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
ESZOPICLONE USP
Issue/Submission Date
2013-02-13
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ETRAVIRINE
Issue/Submission Date
2014-03-07
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
ETRAVIRINE
Issue/Submission Date
2014-03-07
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
EXEMESTANE
Issue/Submission Date
2013-05-31
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
EXEMESTANE
Issue/Submission Date
2013-05-31
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FAMOTIDINE USP
Issue/Submission Date
2005-04-06
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
FAMOTIDINE USP
Issue/Submission Date
2005-04-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FEBUXOSTAT
Issue/Submission Date
2012-12-31
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
FEBUXOSTAT
Issue/Submission Date
2012-12-31
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FESOTERODINE FUMARATE
Issue/Submission Date
2012-08-17
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
FESOTERODINE FUMARATE
Issue/Submission Date
2012-08-17
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-03-28
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 - Complete
 
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-03-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FLUVOXAMINE MALEATE USP
Issue/Submission Date
1999-11-12
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
FLUVOXAMINE MALEATE USP
Issue/Submission Date
1999-11-12
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
GAMMA-HYDROXYBUTYRATE
Issue/Submission Date
1987-12-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GAMMA-HYDROXYBUTYRATE
Issue/Submission Date
1987-12-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GATIFLOXACIN HEMIHYDRATE
Issue/Submission Date
2007-07-13
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
GATIFLOXACIN HEMIHYDRATE
Issue/Submission Date
2007-07-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IBANDRONATE SODIUM
Issue/Submission Date
2007-05-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IBANDRONATE SODIUM
Issue/Submission Date
2007-05-11
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LAMOTRIGINE
Issue/Submission Date
2007-01-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LAMOTRIGINE
Issue/Submission Date
2007-01-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LANSOPRAZOLE USP
Issue/Submission Date
2011-11-08
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
Indian CDSCO WC-0128
Status
Expired - 2016-07-02
Filing Details
Lansoprazole (USP) 
Issue/Submission Date
2014-03-06