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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Amino Chemicals Ltd

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(R)-MODAFINIL

ADAPALENE

BENAZEPRIL HYDROCHLORIDE

BOSENTAN MONOHYDRATE

DEXLANSOPRAZOLE

DEXLANSOPRAZOLE ANHYDROUS

DICLOFENAC EPOLAMINE

FESOTERODINE FUMARATE

FOSINOPRIL SODIUM

Fexofenadine hydrochloride

GRANISETRON HYDROCHLORIDE

IMIQUIMOD

MIGLUSTAT

OLMESARTAN MEDOXOMIL

PALIPERIDONE USP

PANTOPRAZOLE SODIUM SESQUIHYDRATE

PRAMIPEXOLE BASE

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

RABEPRAZOLE SODIUM MONOHYDRATE

RASAGILINE MESYLATE

RUFINAMIDE USP

SAPROPTERIN DIHYDROCHLORIDE

TELMISARTAN

TERBINAFINE HYDROCHLORIDE

TOLTERODINE TARTRATE

VENLAFAXINE HYDROCHLORIDE

VORTIOXETINE HYDROBROMIDE MONOHYDRATE

ZALEPLON

ZIPRASIDONE HYDROCHLORIDE ANHYDROUS

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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217MF11297

220MF10014

221MF10044

223MF10120

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ADAPALENE
Issue/Submission Date
2006-12-27
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ADAPALENE
Issue/Submission Date
2006-12-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENAZEPRIL HYDROCHLORIDE
Issue/Submission Date
2006-02-02
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Benazepril hydrochloride "KOA" at A...
Issue/Submission Date
2005-12-22
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
BENAZEPRIL HYDROCHLORIDE
Benazepril hydrochloride "KOA" at A...
Issue/Submission Date
2006-02-02
2005-12-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BOSENTAN MONOHYDRATE
Issue/Submission Date
2010-01-14
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 - N/A
 
Filing Details
BOSENTAN MONOHYDRATE
Issue/Submission Date
2010-01-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEXLANSOPRAZOLE
Issue/Submission Date
2009-12-16
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
DEXLANSOPRAZOLE
Issue/Submission Date
2009-12-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEXLANSOPRAZOLE ANHYDROUS
Issue/Submission Date
2011-04-15
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
DEXLANSOPRAZOLE ANHYDROUS
Issue/Submission Date
2011-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC EPOLAMINE
Issue/Submission Date
2012-01-04
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 - N/A
 
Filing Details
DICLOFENAC EPOLAMINE
Issue/Submission Date
2012-01-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FESOTERODINE FUMARATE
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 - Complete
 
Filing Details
FESOTERODINE FUMARATE
Issue/Submission Date
2011-06-16
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
Fexofenadine hydrochloride at A61, ...
Issue/Submission Date
2011-07-28
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Fexofenadine hydrochloride at A61, ...
Issue/Submission Date
2011-07-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FOSINOPRIL SODIUM
Issue/Submission Date
2001-02-28
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
FOSINOPRIL SODIUM
Issue/Submission Date
2001-02-28
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
GRANISETRON HYDROCHLORIDE
Issue/Submission Date
2004-06-18
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Granisetron hydrochloride at A61, I...
Issue/Submission Date
2008-01-09
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
GRANISETRON HYDROCHLORIDE
Granisetron hydrochloride at A61, I...
Issue/Submission Date
2004-06-18
2008-01-09
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
IMIQUIMOD
Issue/Submission Date
2007-07-30
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IMIQUIMOD
Issue/Submission Date
2007-07-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MIGLUSTAT
Issue/Submission Date
2015-06-09
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
MIGLUSTAT
Issue/Submission Date
2015-06-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
(R)-MODAFINIL
Issue/Submission Date
2009-10-02
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
(R)-MODAFINIL
Issue/Submission Date
2009-10-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
OLMESARTAN MEDOXOMIL
Issue/Submission Date
2009-04-14
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
OLMESARTAN MEDOXOMIL
Issue/Submission Date
2009-04-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PALIPERIDONE USP
Issue/Submission Date
2010-10-06
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PALIPERIDONE USP
Issue/Submission Date
2010-10-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Issue/Submission Date
2007-01-24
Supporting Info
CEP/COS

Application Number
Status
EXPIRED
Filing Details
Pantoprazole sodium sesquihydrate
Issue/Submission Date
2010-07-21
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
EXPIRED
 
Filing Details
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Pantoprazole sodium sesquihydrate
Issue/Submission Date
2007-01-24
2010-07-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PRAMIPEXOLE BASE
Issue/Submission Date
2018-11-07
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 - N/A
 
Filing Details
PRAMIPEXOLE BASE
Issue/Submission Date
2018-11-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Issue/Submission Date
2005-04-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pramipexole dihydrochloride monohyd...
Issue/Submission Date
2018-09-25
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
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Pramipexole dihydrochloride monohyd...
Issue/Submission Date
2005-04-21
2018-09-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
RABEPRAZOLE SODIUM MONOHYDRATE
Issue/Submission Date
2007-08-29
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
RABEPRAZOLE SODIUM MONOHYDRATE
Issue/Submission Date
2007-08-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RASAGILINE MESYLATE
Issue/Submission Date
2009-03-25
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RASAGILINE MESYLATE
Issue/Submission Date
2009-03-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
RUFINAMIDE USP
Issue/Submission Date
2012-01-04
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
RUFINAMIDE USP
Issue/Submission Date
2012-01-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
SAPROPTERIN DIHYDROCHLORIDE
Issue/Submission Date
2012-12-06
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
SAPROPTERIN DIHYDROCHLORIDE
Issue/Submission Date
2012-12-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TELMISARTAN
Issue/Submission Date
2007-09-26
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Telmisartan
Issue/Submission Date
2012-10-11
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 HOLDER
 
Filing Details
TELMISARTAN
Telmisartan
Issue/Submission Date
2007-09-26
2012-10-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TERBINAFINE HYDROCHLORIDE
Issue/Submission Date
2002-11-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Terbinafine hydrochloride
Issue/Submission Date
2017-09-04
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Terbinafine hydrochloride at A61, I...
Issue/Submission Date
2009-02-25
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
TERBINAFINE HYDROCHLORIDE
Terbinafine hydrochloride
Terbinafine hydrochloride at A61, I...
Issue/Submission Date
2002-11-28
2017-09-04
2009-02-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TOLTERODINE TARTRATE
Issue/Submission Date
2006-12-21
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 - N/A
 
Filing Details
TOLTERODINE TARTRATE
Issue/Submission Date
2006-12-21
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
VENLAFAXINE HYDROCHLORIDE
Issue/Submission Date
2005-10-14
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
VENLAFAXINE HYDROCHLORIDE
Issue/Submission Date
2005-10-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
VORTIOXETINE HYDROBROMIDE MONOHYDRA...
Issue/Submission Date
2017-04-06
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
VORTIOXETINE HYDROBROMIDE MONOHYDRA...
Issue/Submission Date
2017-04-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZALEPLON
Issue/Submission Date
2003-08-20
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
ZALEPLON
Issue/Submission Date
2003-08-20
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
ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
Issue/Submission Date
2006-12-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ziprasidone hydrochloride monohydra...
Issue/Submission Date
2017-09-29
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
VALID
 
Filing Details
ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
Ziprasidone hydrochloride monohydra...
Issue/Submission Date
2006-12-27
2017-09-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2013-07-15
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2013-07-15
Supporting Info

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