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

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ALPRAZOLAM USP

Alprazolam

Amoxapine

Apixaban

BRIMONIDINE TARTRATE USP

Benzydamine Hydrochloride BP

Bromazepam

Brotizolam (EP)

CHLORDIAZEPOXIDE USP

CHLORZOXAZONE USP

CLOBAZAM

CLONAZEPAM USP

Chlorazepate dipotassium

Chlorop amine Hydrochloride (IH)

DABIGATRAN ETEXILATE MESYLATE

DIAZEPAM USP

ES-ZOPICLONE USP

Estazolam (IH)

FLUPHENAZINE HCL

Fampridine

Flunitrazepam

Flupentixol Dihydrochloride BP/EP

Flurazepam Monohydrochloride

LEVOMILNACIPRAN HYDROCHLORIDE

LORAZEPAM USP

LOXAPINE SUCCINATE USP

Linagliptin

Lormetazepam

Loxapine HCl

METOLAZONE USP

MILNACIPRAN HYDROCHLORIDE

Melitracen H drochloride IH

Memantine HCL

Methyl phenidate H drochloride BP/EP/USP

Metopimazine IH

Midazolam BP/EP/USP

Midazolam H drochloride IH

Midazolam Maleate IH

NORTRIPTYLINE HCI USP

Nimorazole IH

Nitrazepam

OXAZEPAM USP

Olopatadine Hydrochloride (USP)

PINDOLOL USP

Pitofenone H drochloride IH

Prasugrel HCl

Prazepam EP

Propiomazine maleate

Propiverine Hydrochloride IH

Rebamipide

Rivastigmine Hydrogen Tartrate IH

Sodium Oxybate (Gamma Hydroxylbutyrate Sodium)

TEMAZEPAM USP

TETRABENAZINE

TIMOLOL MALEATE USP

TRANYLCYPROMINE SULFATE USP

Tetrazepam

Tiemonium Meth I Sulfate IH

Tranylcypromine Sulphate BP

Triazolam USP

ZALEPLON USP

ZOLPIDEM TARTRATE USP

ZOPICLONE

Zopiclone (BP/EP)

clotiazepam

ethyl loflazepate

etizolam

fludiazepam

saxagliptin

tiemonium iodide

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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224MF10202

225MF10082

225MF10155

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WC-0107

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USDMF

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

Application Number
Status
VALID
Filing Details
Alprazolam
Issue/Submission Date
2018-07-02
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
Alprazolam
Issue/Submission Date
2018-07-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ALPRAZOLAM USP
Issue/Submission Date
2007-08-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alprazolam Process B
Issue/Submission Date
2017-06-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Alprazolam (IP/BP/EP/USP/JP)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ALPRAZOLAM USP
Alprazolam Process B
Alprazolam (IP/BP/EP/USP/JP)
Issue/Submission Date
2007-08-30
2017-06-06
2016-06-17
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
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-0107
Status
Valid - 2019-07-02
Filing Details
Benzydamine Hydrochloride BP
Issue/Submission Date
2016-09-12
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Benzydamine Hydrochloride BP
Issue/Submission Date
2016-09-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BRIMONIDINE TARTRATE USP
Issue/Submission Date
2010-06-09
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 - N/A
 
Filing Details
BRIMONIDINE TARTRATE USP
Issue/Submission Date
2010-06-09
Supporting Info
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USDMF

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

Application Number
Status
VALID
Filing Details
Bromazepam
Issue/Submission Date
2017-06-06
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
Bromazepam
Issue/Submission Date
2017-06-06
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
Brotizolam at "CENTAUR HOUSE", NEAR...
Issue/Submission Date
2013-04-23
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Brotizolam (EP)
Issue/Submission Date
2017-01-11
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Brotizolam at "CENTAUR HOUSE", NEAR...
Brotizolam (EP)
Issue/Submission Date
2013-04-23
2017-01-11
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLORDIAZEPOXIDE USP
Issue/Submission Date
2011-09-29
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Chlordiaze oxide IP/BP/EP/USP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CHLORDIAZEPOXIDE USP
Chlordiazepoxide
Chlordiaze oxide IP/BP/EP/USP
Issue/Submission Date
2011-09-29
2017-06-06
2016-06-17
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-0107
Status
Valid - 2019-07-02
Filing Details
Chlorop amine Hydrochloride (IH)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Chlorop amine Hydrochloride (IH)
Issue/Submission Date
2016-06-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLORZOXAZONE USP
Issue/Submission Date
2017-09-29
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
CHLORZOXAZONE USP
Issue/Submission Date
2017-09-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOBAZAM
Issue/Submission Date
2015-05-29
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
clobazam (BP/EP/IP)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CLOBAZAM
Clobazam
clobazam (BP/EP/IP)
Issue/Submission Date
2015-05-29
2017-06-06
2016-06-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLONAZEPAM USP
Issue/Submission Date
2009-02-17
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Clonazepam (IP/BP/EP/USP)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CLONAZEPAM USP
Clonazepam
Clonazepam (IP/BP/EP/USP)
Issue/Submission Date
2009-02-17
2017-06-06
2016-06-17
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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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
Issue/Submission Date
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
DIAZEPAM USP
Issue/Submission Date
2008-07-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diazepam
Issue/Submission Date
2019-01-15
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Diazepam IP/BP/EP/USP
Issue/Submission Date
2016-09-12
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
DIAZEPAM USP
Diazepam
Diazepam IP/BP/EP/USP
Issue/Submission Date
2008-07-24
2019-01-15
2016-09-12
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-0107
Status
Valid - 2019-07-02
Filing Details
Estazolam (IH)
Issue/Submission Date
2017-01-11
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Estazolam (IH)
Issue/Submission Date
2017-01-11
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
ES-ZOPICLONE USP
Issue/Submission Date
2012-06-07
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ES-ZOPICLONE USP
Issue/Submission Date
2012-06-07
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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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
Etizolam at "CENTAUR HOUSE", NEAR G...
Issue/Submission Date
2013-08-12
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Etizolam at "CENTAUR HOUSE", NEAR G...
Issue/Submission Date
2013-08-12
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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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
Issue/Submission Date
Supporting Info
See all info for this product

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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
Issue/Submission Date
Supporting Info
See all info for this product

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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-0107
Status
Valid - 2019-07-02
Filing Details
Flupentixol Dihydrochloride BP/EP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Flupentixol Dihydrochloride BP/EP
Issue/Submission Date
2016-06-17
Supporting Info
See all info for this product

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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
Issue/Submission Date
Supporting Info
See all info for this product

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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
Issue/Submission Date
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
LEVOMILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2017-04-28
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
LEVOMILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2017-04-28
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
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
LORAZEPAM USP
Issue/Submission Date
2009-01-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lorazepam
Issue/Submission Date
2019-02-07
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Lorazepam BP/EP/USP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
LORAZEPAM USP
Lorazepam
Lorazepam BP/EP/USP
Issue/Submission Date
2009-01-23
2019-02-07
2016-06-17
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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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
Issue/Submission Date
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
LOXAPINE SUCCINATE USP
Issue/Submission Date
2015-11-06
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
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Loxapine Succinate USP
Issue/Submission Date
2017-01-11
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
LOXAPINE SUCCINATE USP
Loxapine Succinate USP
Issue/Submission Date
2015-11-06
2017-01-11
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-0107
Status
Valid - 2019-07-02
Filing Details
Melitracen H drochloride IH
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Melitracen H drochloride IH
Issue/Submission Date
2016-06-17
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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Japanese DMF

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

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
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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-0107
Status
Valid - 2019-07-02
Filing Details
Methyl phenidate H drochloride BP/E...
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Methyl phenidate H drochloride BP/E...
Issue/Submission Date
2016-06-17
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METOLAZONE USP
Issue/Submission Date
2016-03-21
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Metolazone (BP/EP/USP)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
METOLAZONE USP
Metolazone (BP/EP/USP)
Issue/Submission Date
2016-03-21
2016-06-17
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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
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Metopimazine IH
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Metopimazine IH
Issue/Submission Date
2016-06-17
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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
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Midazolam BP/EP/USP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Midazolam BP/EP/USP
Issue/Submission Date
2016-06-17
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-0107
Status
Valid - 2019-07-02
Filing Details
Midazolam H drochloride IH
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Midazolam H drochloride IH
Issue/Submission Date
2016-06-17
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-0107
Status
Valid - 2019-07-02
Filing Details
Midazolam Maleate IH
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Midazolam Maleate IH
Issue/Submission Date
2016-06-17
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2012-12-03
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
MILNACIPRAN HYDROCHLORIDE
Issue/Submission Date
2012-12-03
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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
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Nimorazole IH
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Nimorazole IH
Issue/Submission Date
2016-06-17
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USDMF

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

Application Number
Status
VALID
Filing Details
Nitrazepam
Issue/Submission Date
2017-06-08
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Nitrazepam IP/BP/EP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
VALID
 
Valid - 2019-07-02
Filing Details
Nitrazepam
Nitrazepam IP/BP/EP
Issue/Submission Date
2017-06-08
2016-06-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
NORTRIPTYLINE HCI USP
Issue/Submission Date
2011-10-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Nortriptyline hydrochloride
Issue/Submission Date
2017-06-08
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Nortryptyline Hydrochloride IP/BP/E...
Issue/Submission Date
2016-09-12
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
NORTRIPTYLINE HCI USP
Nortriptyline hydrochloride
Nortryptyline Hydrochloride IP/BP/E...
Issue/Submission Date
2011-10-07
2017-06-08
2016-09-12
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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
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Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Olopatadine Hydrochloride (USP)
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
 
Valid - 2019-07-02
Filing Details
Olopatadine Hydrochloride (USP)
Issue/Submission Date
2016-06-17
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OXAZEPAM USP
Issue/Submission Date
2008-09-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Oxazepam
Issue/Submission Date
2017-06-08
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0107
Status
Valid - 2019-07-02
Filing Details
Oxazepam IP/BP/EP/USP
Issue/Submission Date
2016-06-17
Supporting Info
Application Number
Indian CDSCO WC-0107
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
OXAZEPAM USP
Oxazepam
Oxazepam IP/BP/EP/USP
Issue/Submission Date
2008-09-30
2017-06-08
2016-06-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PINDOLOL USP
Issue/Submission Date
2017-04-07
Supporting Info
CEP/COS

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

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

Application Number
Status