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

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ALVIMOPAN DIHYDRATE

AMBRISENTAN

APIXABAN

ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)

Betaxolol Hydrochloride (BP/EP)

CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE)

CYCLOSPORINE

Celecoxib (EP)

DEFERASIROX

DOCOSANOL

DOXYCYCLINE

ENZALUTAMIDE

FERRIC CITRATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG

HYDROCODONE BITARTRATE TABLETS, 10 MG

IMIQUIMOD

IMIQUIMOD USP [NON-STERILE DRUG SUBSTANCE]

IRON DEXTRAN, 5% SOLUTION

LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE

MANUFACTURING SITE, FACILITIES , PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIBERTYVILLE, ILLINOIS.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERAING PROCEDURES IN CORONA, CALIFORNIA.

MESTRANOL 3-METHOXY-172-ETHINYL-ESTRADIOL- MANUF PROCEDURES

METOPROLOL SUCCINATE USP

METOPROLOL TARTRATE USP

MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

Moxonidine

NABUMETONE USP

NICOTINE

NICOTINE BITARTRATE DIHYDRATE

NICOTINE POLACRILEX RESIN

NITROFURANTOIN MACROCRYSTALS USP

NITROFURANTOIN MONOHYDRATE USP

NORETHINDRONE

NORTRIPTYLINE HYDROCHLORIDE USP

OXYBUTYNIN BASE

OXYBUTYNIN CHLORIDE USP

PRILOCAINE USP

PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG.

Piroxicam

RAMIPRIL USP

RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)

ROPINIROLE HYDROCHLORIDE USP

Repaglinide

SUCROFERRIC OXYHYDROXIDE

TAZAROTENE

TELMISARTAN

TIZANIDINE HYDROCHLORIDE USP

TRANSDERMAL ESTRADIOL PATCH

TRIENTINE HYDROCHLORIDE USP

VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY EDQM

WITHDRAWN BY HOLDER

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220MF10258

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WC-0199

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2016-05-24
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 - Complete
 
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2016-05-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMBRISENTAN
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMBRISENTAN
Issue/Submission Date
2011-09-09
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
APIXABAN
Issue/Submission Date
2016-07-29
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
APIXABAN
Issue/Submission Date
2016-07-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARMODAFINIL (NON STERILE BULK DRUG ...
Issue/Submission Date
2009-07-24
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
ARMODAFINIL (NON STERILE BULK DRUG ...
Issue/Submission Date
2009-07-24
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-0199
Status
Valid - 2019-07-02
Filing Details
Betaxolol Hydrochloride (BP/EP)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0199
Status
 
Valid - 2019-07-02
Filing Details
Betaxolol Hydrochloride (BP/EP)
Issue/Submission Date
2016-06-15
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-0199
Status
Valid - 2019-07-02
Filing Details
Celecoxib (EP)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0199
Status
 
Valid - 2019-07-02
Filing Details
Celecoxib (EP)
Issue/Submission Date
2016-06-15
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
CINACALCET HYDROCHLORIDE (NON-STERI...
Issue/Submission Date
2010-06-23
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
CINACALCET HYDROCHLORIDE (NON-STERI...
Issue/Submission Date
2010-06-23
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYCLOSPORINE
Issue/Submission Date
2001-03-14
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CYCLOSPORINE
Issue/Submission Date
2001-03-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEFERASIROX
Issue/Submission Date
2015-07-27
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
DEFERASIROX
Issue/Submission Date
2015-07-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DOCOSANOL
Issue/Submission Date
2015-06-19
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
DOCOSANOL
Issue/Submission Date
2015-06-19
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOXYCYCLINE
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
DOXYCYCLINE
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
ENZALUTAMIDE
Issue/Submission Date
2016-05-24
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 - Complete
 
Filing Details
ENZALUTAMIDE
Issue/Submission Date
2016-05-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
TRANSDERMAL ESTRADIOL PATCH
Issue/Submission Date
1990-10-02
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
TRANSDERMAL ESTRADIOL PATCH
Issue/Submission Date
1990-10-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FERRIC CITRATE
Issue/Submission Date
2015-02-27
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
FERRIC CITRATE
Issue/Submission Date
2015-02-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYDROCODONE BITARTRATE AND ACETAMIN...
Issue/Submission Date
1996-07-03
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HYDROCODONE BITARTRATE AND ACETAMIN...
Issue/Submission Date
1996-07-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYDROCODONE BITARTRATE TABLETS, 10 ...
Issue/Submission Date
1996-07-03
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HYDROCODONE BITARTRATE TABLETS, 10 ...
Issue/Submission Date
1996-07-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IMIQUIMOD
Issue/Submission Date
2005-09-19
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
IMIQUIMOD
Issue/Submission Date
2005-09-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IMIQUIMOD USP [NON-STERILE DRUG SUB...
Issue/Submission Date
2008-05-08
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IMIQUIMOD USP [NON-STERILE DRUG SUB...
Issue/Submission Date
2008-05-08
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
IRON DEXTRAN, 5% SOLUTION
Issue/Submission Date
1990-10-31
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
IRON DEXTRAN, 5% SOLUTION
Issue/Submission Date
1990-10-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LETROZOLE USP NON-STERILE BULK DRUG...
Issue/Submission Date
2007-05-29
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
LETROZOLE USP NON-STERILE BULK DRUG...
Issue/Submission Date
2007-05-29
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METOPROLOL SUCCINATE USP
Issue/Submission Date
2008-10-13
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
METOPROLOL SUCCINATE USP
Issue/Submission Date
2008-10-13
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METOPROLOL TARTRATE USP
Issue/Submission Date
2008-09-26
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Metoprolol tartrate
Issue/Submission Date
2012-07-24
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0199
Status
Valid - 2019-07-02
Filing Details
Metoprolol Tartrate BP/EP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0199
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
WITHDRAWN BY HOLDER
 
Valid - 2019-07-02
Filing Details
METOPROLOL TARTRATE USP
Metoprolol tartrate
Metoprolol Tartrate BP/EP
Issue/Submission Date
2008-09-26
2012-07-24
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MIDODRINE HYDROCHLORIDE, NON-STERIL...
Issue/Submission Date
2002-09-16
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
MIDODRINE HYDROCHLORIDE, NON-STERIL...
Issue/Submission Date
2002-09-16
Supporting Info
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USDMF

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

Application Number
Status
EXPIRED
Filing Details
Moxonidine
Issue/Submission Date
2007-06-01
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
EXPIRED
 
Filing Details
Moxonidine
Issue/Submission Date
2007-06-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NABUMETONE USP
Issue/Submission Date
2008-12-22
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0199
Status
Valid - 2019-07-02
Filing Details
Nabumetone (BP/EP)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0199
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
NABUMETONE USP
Nabumetone (BP/EP)
Issue/Submission Date
2008-12-22
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NICOTINE
Issue/Submission Date
1989-01-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Nicotine
Issue/Submission Date
2019-02-25
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
NICOTINE
Nicotine
Issue/Submission Date
1989-01-21
2019-02-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
NICOTINE BITARTRATE DIHYDRATE
Issue/Submission Date
1997-07-11
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
NICOTINE BITARTRATE DIHYDRATE
Issue/Submission Date
1997-07-11
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
NICOTINE POLACRILEX RESIN
Issue/Submission Date
1994-02-01
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
NICOTINE POLACRILEX RESIN
Issue/Submission Date
1994-02-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NITROFURANTOIN MACROCRYSTALS USP
Issue/Submission Date
2001-07-11
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
NITROFURANTOIN MACROCRYSTALS USP
Issue/Submission Date
2001-07-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NITROFURANTOIN MONOHYDRATE USP
Issue/Submission Date
2003-04-22
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
NITROFURANTOIN MONOHYDRATE USP
Issue/Submission Date
2003-04-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NORETHINDRONE
Issue/Submission Date
1957-01-11
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NORETHINDRONE
Issue/Submission Date
1957-01-11
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NORTRIPTYLINE HYDROCHLORIDE USP
Issue/Submission Date
2008-01-31
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 - N/A
 
Filing Details
NORTRIPTYLINE HYDROCHLORIDE USP
Issue/Submission Date
2008-01-31
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OXYBUTYNIN BASE
Issue/Submission Date
2012-06-13
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
OXYBUTYNIN BASE
Issue/Submission Date
2012-06-13
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OXYBUTYNIN CHLORIDE USP
Issue/Submission Date
2012-10-22
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
OXYBUTYNIN CHLORIDE USP
Issue/Submission Date
2012-10-22
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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
Piroxicam at 201/301, Corporate Enc...
Issue/Submission Date
2008-12-22
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Piroxicam at 201/301, Corporate Enc...
Issue/Submission Date
2008-12-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PRILOCAINE USP
Issue/Submission Date
2001-12-18
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
PRILOCAINE USP
Issue/Submission Date
2001-12-18
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PROGESTERONE VAGINAL SUPPOSITORY 10...
Issue/Submission Date
1993-02-26
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PROGESTERONE VAGINAL SUPPOSITORY 10...
Issue/Submission Date
1993-02-26
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
RAMIPRIL USP
Issue/Submission Date
2008-02-28
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RAMIPRIL USP
Issue/Submission Date
2008-02-28
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USDMF

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

Application Number
Status
VALID
Filing Details
Repaglinide
Issue/Submission Date
2017-02-16
Supporting Info
Japanese DMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Repaglinide
Issue/Submission Date
2017-02-16
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RIVASTIGMINE HYDROGEN TARTRATE (NON...
Issue/Submission Date
2009-11-10
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 - N/A
 
Filing Details
RIVASTIGMINE HYDROGEN TARTRATE (NON...
Issue/Submission Date
2009-11-10
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ROPINIROLE HYDROCHLORIDE USP
Issue/Submission Date
2008-02-07
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
ROPINIROLE HYDROCHLORIDE USP
Issue/Submission Date
2008-02-07
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
SUCROFERRIC OXYHYDROXIDE
Issue/Submission Date
2015-06-19
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
SUCROFERRIC OXYHYDROXIDE
Issue/Submission Date
2015-06-19
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
TAZAROTENE
Issue/Submission Date
2006-12-13
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TAZAROTENE
Issue/Submission Date
2006-12-13
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TELMISARTAN
Issue/Submission Date
2008-11-18
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY EDQM
Filing Details
Telmisartan
Issue/Submission Date
2013-01-22
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
WITHDRAWN BY EDQM
 
Filing Details
TELMISARTAN
Telmisartan
Issue/Submission Date
2008-11-18
2013-01-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TIZANIDINE HYDROCHLORIDE USP
Issue/Submission Date
2002-01-22
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 - N/A
 
Filing Details
TIZANIDINE HYDROCHLORIDE USP
Issue/Submission Date
2002-01-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TRIENTINE HYDROCHLORIDE USP
Issue/Submission Date
2015-08-27
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
TRIENTINE HYDROCHLORIDE USP
Issue/Submission Date
2015-08-27
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
VARENICLINE TARTRATE MALTODEXTRIN P...
Issue/Submission Date
2010-05-06
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
VARENICLINE TARTRATE MALTODEXTRIN P...
Issue/Submission Date
2010-05-06
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2010-12-01
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
ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2010-12-01
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MESTRANOL 3-METHOXY-172-ETHINYL-ES...
Issue/Submission Date
1960-12-28
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MESTRANOL 3-METHOXY-172-ETHINYL-ES...
Issue/Submission Date
1960-12-28
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES , PE...
Issue/Submission Date
1984-02-08
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
MANUFACTURING SITE, FACILITIES , PE...
Issue/Submission Date
1984-02-08
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1985-09-11
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