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

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ABIRATERONE ACETATE USP

APREMILAST

ATAZANAVIR SULFATE

ATORVASTATIN CALCIUM STABILIZED

AZATHIOPRINE USP

BACITRACIN

BACITRACIN ZINC

BOSENTAN MONOHYDRATE

BREXPIPRAZOLE

CALCIUM AMPHOMYCIN

CARVEDILOL USP

CELECOXIB, USP

CHLORPROMAZINE HYDROCHLORIDE USP

CITALOPRAM HYDROBROMIDE, USP

CLOBAZAM

CLOPIDOGREL BISULFATE, USP

DAPAGLIFLOZIN

DARUNAVIR

DEXLANSOPRAZOLE (ROUTE CODE - DR)

DEXLANSOPRAZOLE API

DIMETHYL FUMARATE

DIVALPROEX SODIUM USP

DOXYCYCLINE HYCLATE, USP

DOXYCYCLINE USP

DRONEDARONE HYDROCHLORIDE USP

ELIGLUSTAT HEMITARTRATE

ELTROMBOPAG OLAMINE

ESCITALOPRAM OXALATE, USP

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES")

EZETIMIBE USP

FELBAMATE, USP

FESOTERODINE FUMARATE

FLUPHENAZINE HYDROCHLORIDE USP

LEVOMILNACIPRAN HYDROCHLORIDE

LINEZOLID USP

LURASIDONE HYDROCHLORIDE

Lurasidone

MACITENTAN

METAXALONE USP

MILNACIPRAN HYDROCHLORIDE, API

OMEPRAZOLE MAGNESIUM, USP

OMEPRAZOLE, USP

OSELTAMIVIR PHOSPHATE USP

Omeprazole Magnesium

Onglyza Hydrate

PANTOPRAZOLE SODIUM USP

PIRFENIDONE

POTASSIUM DOBESILATE

QUETIAPINE FUMARATE USP

RABEPRAZOLE SODIUM USP

RALOXIFENE HYDROCHLORIDE, USP

RANOLAZINE

RIFAXIMIN

RITONAVIR, USP (FORM-I)

RIVAROXABAN

SACUBITRIL SODIUM

SALSALATE USP

SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

SILDENAFIL CITRATE USP

SOLIFENACIN SUCCINATE

TERIFLUNOMIDE

TICAGRELOR

TRAMADOL HYDROCHLORIDE USP

TRAMADOL HYDROCHLORIDE USP API (PROCESS-2)

Tramadol Hydrochloride

VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP

VORTIOXETINE HYDROBROMIDE SOLVATE

WARFARIN SODIUM CLATHRATE USP

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP

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Status - Active

Status - Inactive

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VALID

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Blank

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WC-0305

WC-305

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ABIRATERONE ACETATE USP
Issue/Submission Date
2014-12-23
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
ABIRATERONE ACETATE USP
Issue/Submission Date
2014-12-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST
Issue/Submission Date
2016-12-29
Supporting Info
CEP/COS

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

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

Application Number
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
2016-12-29
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
2015-12-17
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
ATAZANAVIR SULFATE
Issue/Submission Date
2015-12-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM STABILIZED
Issue/Submission Date
2012-05-22
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
ATORVASTATIN CALCIUM STABILIZED
Issue/Submission Date
2012-05-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZATHIOPRINE USP
Issue/Submission Date
2009-10-13
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AZATHIOPRINE USP
Issue/Submission Date
2009-10-13
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BACITRACIN
Issue/Submission Date
1998-09-01
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BACITRACIN
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BACITRACIN ZINC
Issue/Submission Date
1998-09-01
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BACITRACIN ZINC
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BOSENTAN MONOHYDRATE
Issue/Submission Date
2018-04-30
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
BOSENTAN MONOHYDRATE
Issue/Submission Date
2018-04-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BREXPIPRAZOLE
Issue/Submission Date
2018-12-26
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
BREXPIPRAZOLE
Issue/Submission Date
2018-12-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CALCIUM AMPHOMYCIN
Issue/Submission Date
1998-09-01
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CALCIUM AMPHOMYCIN
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARVEDILOL USP
Issue/Submission Date
2010-04-13
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CARVEDILOL USP
Issue/Submission Date
2010-04-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CELECOXIB, USP
Issue/Submission Date
2011-12-28
CEP/COS

Application Number
Status
VALID
Filing Details
Celecoxib
Issue/Submission Date
2017-08-30
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Indian CDSCO WC-305
Status
Expired - 2017-11-17
Filing Details
Celecoxib (Ph.Eur.)
Issue/Submission Date
2014-11-17
Application Number
Indian CDSCO WC-305
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Expired - 2017-11-17
Filing Details
CELECOXIB, USP
Celecoxib
Celecoxib (Ph.Eur.)
Issue/Submission Date
2011-12-28
2017-08-30
2014-11-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLORPROMAZINE HYDROCHLORIDE USP
Issue/Submission Date
2018-07-09
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 - Complete
 
Filing Details
CHLORPROMAZINE HYDROCHLORIDE USP
Issue/Submission Date
2018-07-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CITALOPRAM HYDROBROMIDE, USP
Issue/Submission Date
2011-06-16
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CITALOPRAM HYDROBROMIDE, USP
Issue/Submission Date
2011-06-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOBAZAM
Issue/Submission Date
2016-05-30
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
CLOBAZAM
Issue/Submission Date
2016-05-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOPIDOGREL BISULFATE, USP
Issue/Submission Date
2018-05-30
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
CLOPIDOGREL BISULFATE, USP
Issue/Submission Date
2018-05-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DAPAGLIFLOZIN
Issue/Submission Date
2017-08-16
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DAPAGLIFLOZIN
Issue/Submission Date
2017-08-16
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
DARUNAVIR
Issue/Submission Date
2016-10-05
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DARUNAVIR
Issue/Submission Date
2016-10-05
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
DEXLANSOPRAZOLE API
Issue/Submission Date
2012-05-23
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 - N/A
 
Filing Details
DEXLANSOPRAZOLE API
Issue/Submission Date
2012-05-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXLANSOPRAZOLE (ROUTE CODE - DR)
Issue/Submission Date
2016-05-13
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
DEXLANSOPRAZOLE (ROUTE CODE - DR)
Issue/Submission Date
2016-05-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DIMETHYL FUMARATE
Issue/Submission Date
2015-12-28
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
DIMETHYL FUMARATE
Issue/Submission Date
2015-12-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIVALPROEX SODIUM USP
Issue/Submission Date
2010-06-23
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DIVALPROEX SODIUM USP
Issue/Submission Date
2010-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOXYCYCLINE USP
Issue/Submission Date
2011-06-16
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DOXYCYCLINE USP
Issue/Submission Date
2011-06-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DOXYCYCLINE HYCLATE, USP
Issue/Submission Date
2012-03-29
CEP/COS

Application Number
Status
VALID
Filing Details
Doxycycline hyclate
Issue/Submission Date
2017-11-03
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
DOXYCYCLINE HYCLATE, USP
Doxycycline hyclate
Issue/Submission Date
2012-03-29
2017-11-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DRONEDARONE HYDROCHLORIDE USP
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Issue/Submission Date
2013-05-31
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
ELIGLUSTAT HEMITARTRATE
Issue/Submission Date
2017-12-14
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ELIGLUSTAT HEMITARTRATE
Issue/Submission Date
2017-12-14
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
ELTROMBOPAG OLAMINE
Issue/Submission Date
2017-04-29
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
ELTROMBOPAG OLAMINE
Issue/Submission Date
2017-04-29
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
ESCITALOPRAM OXALATE, USP
Issue/Submission Date
2013-03-05
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESCITALOPRAM OXALATE, USP
Issue/Submission Date
2013-03-05
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
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
Issue/Submission Date
2015-07-17
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
Issue/Submission Date
2015-07-17
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
EZETIMIBE USP
Issue/Submission Date
2016-12-08
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 - Complete
 
Filing Details
EZETIMIBE USP
Issue/Submission Date
2016-12-08
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
FELBAMATE, USP
Issue/Submission Date
2016-12-28
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
FELBAMATE, USP
Issue/Submission Date
2016-12-28
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FESOTERODINE FUMARATE
Issue/Submission Date
2012-08-30
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
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FESOTERODINE FUMARATE
Issue/Submission Date
2012-08-30
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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FLUPHENAZINE HYDROCHLORIDE USP
Issue/Submission Date
2018-11-29
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
FLUPHENAZINE HYDROCHLORIDE USP
Issue/Submission Date
2018-11-29
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LEVOMILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2014-04-10
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
LEVOMILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2014-04-10
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LINEZOLID USP
Issue/Submission Date
2012-05-08
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LINEZOLID USP
Issue/Submission Date
2012-05-08
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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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LURASIDONE HYDROCHLORIDE
Issue/Submission Date
2014-06-04
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
LURASIDONE HYDROCHLORIDE
Issue/Submission Date
2014-06-04
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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MACITENTAN
Issue/Submission Date
2016-12-13
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
MACITENTAN
Issue/Submission Date
2016-12-13
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
METAXALONE USP
Issue/Submission Date
2010-07-19
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
METAXALONE USP
Issue/Submission Date
2010-07-19
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MILNACIPRAN HYDROCHLORIDE, API
Issue/Submission Date
2012-11-19
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
MILNACIPRAN HYDROCHLORIDE, API
Issue/Submission Date
2012-11-19
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
Issue/Submission Date
2013-09-17
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...
Issue/Submission Date
2013-09-17
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OMEPRAZOLE MAGNESIUM, USP
Issue/Submission Date
2013-09-02
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
OMEPRAZOLE MAGNESIUM, USP
Issue/Submission Date
2013-09-02
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OMEPRAZOLE, USP
Issue/Submission Date
2015-06-22
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 - Complete
 
Filing Details
OMEPRAZOLE, USP
Issue/Submission Date
2015-06-22
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USDMF

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Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
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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
 
Filing Details
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OSELTAMIVIR PHOSPHATE USP
Issue/Submission Date
2018-11-28
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
OSELTAMIVIR PHOSPHATE USP
Issue/Submission Date
2018-11-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PANTOPRAZOLE SODIUM USP
Issue/Submission Date
2011-01-31
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
PANTOPRAZOLE SODIUM USP
Issue/Submission Date
2011-01-31
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PIRFENIDONE
Issue/Submission Date
2017-12-21
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
PIRFENIDONE
Issue/Submission Date
2017-12-21
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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POTASSIUM DOBESILATE
Issue/Submission Date
2016-02-25
Supporting Info
CEP/COS

Application Number
Status