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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Divis Laboratories Ltd.

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2-4-WING A ESTER

5-PHENYLHYDANTOIN

A WINGS

B WINGS

BOC COR SUCCINATE (INTERMEDIATE)

BUPROPION HYDROCHLORIDE USP

Bosentan Monohydrate (IH)

Bupropion HCI (USP)

CAPECITABINE

CARBIDOPA USP

Carvedilol (Ph.Eur)

DESLORATADINE

DEXTROMETHORPHAN BASE

DEXTROMETHORPHAN HYDROBROMIDE USP

DILTIAZEM HYDROCHLORIDE USP

Entacapone (Ph.Eur.)

FOSPHENYTOIN SODIUM USP

GABAPENTIN USP

IOPAMIDOL USP

IRBESARTAN USP

KETOENAMINE

KETOROLAC ACID

LEVETIRACETAM

LEVETIRACETAM (PROCESS B)

LEVODOPA USP

LORATADINE USP

Lamotrigine (Ph. Eur/IP/USP)

Losartan potassium

MESALAMINE USP

METHYLDOPA USP

NABUMETONE USP

NAPROXEN SODIUM USP

NAPROXEN USP

NIACIN USP

Naproxen (BP/USP/Ph. Eur)

Naproxen Sodium (Ph. Eur/USP)

OLMESARTAN MEDOXOMIL USP

Orlistate USP

PHENYLEPHRINE HYDROCHLORIDE USP

PREGABALIN

PREGABALIN (ALTERNATIVE PROCESS)

PROGUANIL HYDROCHLORIDE

QUETIAPINE FUMARATE

RISEDRONATE SODIUM

Raltegravir Potassium (IH)

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

SULPHAZINE

SUMATRIPTAN SUCCINATE AND SUMATRIPTAN

Simvastatin (Ph. Eur/IP/USP)

Sitagliptin Phosphate (IP/IH)

Sumatriptan (IP)

TAMSULOSIN HYDROCHLORIDE

TELMISARTAN, USP

TPE ALCOHOL

TRIPEPTIDE, DRUG INTERMEDIATE

TRITYL LOSARTAN

Topiramate

Triprolidine Hydrochloride (IP/USP/BP)

VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS FORM)

VALSARTAN USP

VENLAFAXINE HCL

VERAPAMIL HYDROCHLORIDE USP

VIGABATRIN

VIGABATRIN USP

ZOLPIDEM TARTRATE USP

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Status - Active

Status - Inactive

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217MF10567

220MF10194

221MF10243

224MF10172

224MF10232

225MF10125

227MF10235

228MF10204

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WC-0030

WC-0031

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
5-PHENYLHYDANTOIN
Issue/Submission Date
2002-01-31
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
5-PHENYLHYDANTOIN
Issue/Submission Date
2002-01-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
TPE ALCOHOL
Issue/Submission Date
2007-01-07
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
TPE ALCOHOL
Issue/Submission Date
2007-01-07
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
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Bosentan Monohydrate (IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Bosentan Monohydrate (IH)
Issue/Submission Date
2016-06-23
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-0030
Status
Valid - 2019-06-05
Filing Details
Bupropion HCI (USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Bupropion HCI (USP)
Issue/Submission Date
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUPROPION HYDROCHLORIDE USP
Issue/Submission Date
2005-04-24
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
BUPROPION HYDROCHLORIDE USP
Issue/Submission Date
2005-04-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CAPECITABINE
Issue/Submission Date
2008-10-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Capecitabine
Issue/Submission Date
2018-12-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Capecitabine (USP/ Ph. Eur/IP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
CAPECITABINE
Capecitabine
Capecitabine (USP/ Ph. Eur/IP)
Issue/Submission Date
2008-10-27
2018-12-03
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARBIDOPA USP
Issue/Submission Date
2004-11-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carbidopa
Issue/Submission Date
2018-01-11
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Carbidopa at 1-72 / 23 (P) / DIVIS ...
Issue/Submission Date
2013-07-02
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Carbidopa (IP/BP/USP/Ph. Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
CARBIDOPA USP
Carbidopa
Carbidopa at 1-72 / 23 (P) / DIVIS ...
Carbidopa (IP/BP/USP/Ph. Eur)
Issue/Submission Date
2004-11-20
2018-01-11
2013-07-02
2016-06-23
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-0031
Status
Valid - 2019-06-05
Filing Details
Carvedilol (Ph.Eur)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
 
Valid - 2019-06-05
Filing Details
Carvedilol (Ph.Eur)
Issue/Submission Date
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DESLORATADINE
Issue/Submission Date
2006-05-17
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Desloratadine (IH)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
DESLORATADINE
Desloratadine (IH)
Issue/Submission Date
2006-05-17
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEXTROMETHORPHAN BASE
Issue/Submission Date
2009-01-28
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Dextromethorphan base at Divi Tower...
Issue/Submission Date
2008-08-28
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Dextromethorphan (USP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
DEXTROMETHORPHAN BASE
Dextromethorphan base at Divi Tower...
Dextromethorphan (USP)
Issue/Submission Date
2009-01-28
2008-08-28
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXTROMETHORPHAN HYDROBROMIDE USP
Issue/Submission Date
1997-02-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Dextromethorphan hydrobromide
Issue/Submission Date
2018-07-20
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia dextromethor...
Issue/Submission Date
2005-09-09
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Dextromethorphan HBr (BP/USPIPh.Eur...
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
DEXTROMETHORPHAN HYDROBROMIDE USP
Dextromethorphan hydrobromide
Japanese Pharmacopoeia dextromethor...
Dextromethorphan HBr (BP/USPIPh.Eur...
Issue/Submission Date
1997-02-04
2018-07-20
2005-09-09
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DILTIAZEM HYDROCHLORIDE USP
Issue/Submission Date
2001-01-26
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diltiazem hydrochloride
Issue/Submission Date
2018-09-27
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Diltiazem Hydrochloride (BP/USP/Ph....
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
DILTIAZEM HYDROCHLORIDE USP
Diltiazem hydrochloride
Diltiazem Hydrochloride (BP/USP/Ph....
Issue/Submission Date
2001-01-26
2018-09-27
2016-06-08
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-0030
Status
Valid - 2019-06-05
Filing Details
Entacapone (Ph.Eur.)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Entacapone (Ph.Eur.)
Issue/Submission Date
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FOSPHENYTOIN SODIUM USP
Issue/Submission Date
2005-09-25
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
FOSPHENYTOIN SODIUM USP
Issue/Submission Date
2005-09-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GABAPENTIN USP
Issue/Submission Date
2005-12-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Gabapentin
Issue/Submission Date
2018-05-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Gabapentin at DIVI TOWERS, 7-1-77 /...
Issue/Submission Date
2009-11-15
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Gabapentin (USP/Ph. Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
GABAPENTIN USP
Gabapentin
Gabapentin at DIVI TOWERS, 7-1-77 /...
Gabapentin (USP/Ph. Eur)
Issue/Submission Date
2005-12-04
2018-05-09
2009-11-15
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
IOPAMIDOL USP
Issue/Submission Date
2005-02-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Iopamidol
Issue/Submission Date
2018-12-10
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Iopamidol (USP/Ph.Eur/BP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
IOPAMIDOL USP
Iopamidol
Iopamidol (USP/Ph.Eur/BP)
Issue/Submission Date
2005-02-06
2018-12-10
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
IRBESARTAN USP
Issue/Submission Date
2012-09-11
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Irbesartan
Issue/Submission Date
2018-03-28
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Irbesartan (USP/Ph. Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
IRBESARTAN USP
Irbesartan
Irbesartan (USP/Ph. Eur)
Issue/Submission Date
2012-09-11
2018-03-28
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
KETOROLAC ACID
Issue/Submission Date
1999-08-09
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
KETOROLAC ACID
Issue/Submission Date
1999-08-09
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-0030
Status
Valid - 2019-06-05
Filing Details
Lamotrigine (Ph. Eur/IP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Lamotrigine (Ph. Eur/IP/USP)
Issue/Submission Date
2016-06-23
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
LEVETIRACETAM
Issue/Submission Date
2003-10-05
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Levetiracetam Process B
Issue/Submission Date
2018-08-14
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Levetiracetam (USP/Ph.Eur/BP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
LEVETIRACETAM
Levetiracetam Process B
Levetiracetam (USP/Ph.Eur/BP)
Issue/Submission Date
2003-10-05
2018-08-14
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LEVETIRACETAM (PROCESS B)
Issue/Submission Date
2016-01-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Levetiracetam
Issue/Submission Date
2018-08-01
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
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
LEVETIRACETAM (PROCESS B)
Levetiracetam
Issue/Submission Date
2016-01-08
2018-08-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LEVODOPA USP
Issue/Submission Date
2004-12-03
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Levodopa
Issue/Submission Date
2018-01-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Levodopa at 1-72 / 23 (P) / DIVIS /...
Issue/Submission Date
2015-09-24
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Levodopa (IP/BP/USP/Ph. Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
LEVODOPA USP
Levodopa
Levodopa at 1-72 / 23 (P) / DIVIS /...
Levodopa (IP/BP/USP/Ph. Eur)
Issue/Submission Date
2004-12-03
2018-01-25
2015-09-24
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LORATADINE USP
Issue/Submission Date
2004-11-07
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LORATADINE USP
Issue/Submission Date
2004-11-07
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
VALID
Filing Details
Losartan potassium
Issue/Submission Date
2017-02-15
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Losartan Potassium (Ph. Eur/IP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
VALID
 
Valid - 2019-06-05
Filing Details
Losartan potassium
Losartan Potassium (Ph. Eur/IP/USP)
Issue/Submission Date
2017-02-15
2016-06-23
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
MESALAMINE USP
Issue/Submission Date
2015-11-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mesalazine
Issue/Submission Date
2018-05-16
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Mesalamine (IP/USP/BP/Ph.Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
MESALAMINE USP
Mesalazine
Mesalamine (IP/USP/BP/Ph.Eur)
Issue/Submission Date
2015-11-06
2018-05-16
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METHYLDOPA USP
Issue/Submission Date
2004-09-19
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
METHYLDOPA USP
Issue/Submission Date
2004-09-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NABUMETONE USP
Issue/Submission Date
2001-04-02
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Nabumetone
Issue/Submission Date
2018-08-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Nabumetone at 1-72 / 23 (P) / DIVIS...
Issue/Submission Date
2016-10-31
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Nabumetone (USP/Ph.Eur/BP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
NABUMETONE USP
Nabumetone
Nabumetone at 1-72 / 23 (P) / DIVIS...
Nabumetone (USP/Ph.Eur/BP)
Issue/Submission Date
2001-04-02
2018-08-23
2016-10-31
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NAPROXEN USP
Issue/Submission Date
1998-11-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Naproxen
Issue/Submission Date
2018-02-28
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Naproxen (IP/BP/USP/Ph. Eur./JP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
NAPROXEN USP
Naproxen
Naproxen (IP/BP/USP/Ph. Eur./JP)
Issue/Submission Date
1998-11-27
2018-02-28
2016-06-08
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-0031
Status
Valid - 2019-06-05
Filing Details
Naproxen (BP/USP/Ph. Eur)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
 
Valid - 2019-06-05
Filing Details
Naproxen (BP/USP/Ph. Eur)
Issue/Submission Date
2016-06-08
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NAPROXEN SODIUM USP
Issue/Submission Date
1998-11-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Naproxen sodium
Issue/Submission Date
2018-01-30
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Naproxen Sodium (Ph. Eur/USP/BP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
NAPROXEN SODIUM USP
Naproxen sodium
Naproxen Sodium (Ph. Eur/USP/BP)
Issue/Submission Date
1998-11-27
2018-01-30
2016-06-23
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-0031
Status
Valid - 2019-06-05
Filing Details
Naproxen Sodium (Ph. Eur/USP)
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
 
Valid - 2019-06-05
Filing Details
Naproxen Sodium (Ph. Eur/USP)
Issue/Submission Date
2016-06-08
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NIACIN USP
Issue/Submission Date
2005-07-05
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
NIACIN USP
Issue/Submission Date
2005-07-05
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OLMESARTAN MEDOXOMIL USP
Issue/Submission Date
2014-01-28
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
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Olmesartan Medoxomil (USP/Ph. Eur)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-05
Filing Details
OLMESARTAN MEDOXOMIL USP
Olmesartan Medoxomil (USP/Ph. Eur)
Issue/Submission Date
2014-01-28
2016-06-23
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-0030
Status
Valid - 2019-06-05
Filing Details
Orlistate USP
Issue/Submission Date
2016-10-17
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Orlistate USP
Issue/Submission Date
2016-10-17
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PHENYLEPHRINE HYDROCHLORIDE USP
Issue/Submission Date
2003-10-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Phenylephrine hydrochloride
Issue/Submission Date
2016-06-28
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Phenylephrine HCI (IP/BP/USP/Ph. Eu...
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
PHENYLEPHRINE HYDROCHLORIDE USP
Phenylephrine hydrochloride
Phenylephrine HCI (IP/BP/USP/Ph. Eu...
Issue/Submission Date
2003-10-19
2016-06-28
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PREGABALIN
Issue/Submission Date
2014-05-16
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pregabalin
Issue/Submission Date
2018-07-26
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Pregabalin (IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
PREGABALIN
Pregabalin
Pregabalin (IH)
Issue/Submission Date
2014-05-16
2018-07-26
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PREGABALIN (ALTERNATIVE PROCESS)
Issue/Submission Date
2016-08-01
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
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Pregabalin Ph EUR
Issue/Submission Date
2016-11-25
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-05
Filing Details
PREGABALIN (ALTERNATIVE PROCESS)
Pregabalin Ph EUR
Issue/Submission Date
2016-08-01
2016-11-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PROGUANIL HYDROCHLORIDE
Issue/Submission Date
2005-02-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Proguanil hydrochloride
Issue/Submission Date
2018-02-28
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Proguanil Hydrochloride (BP/USP/Ph....
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-06-05
Filing Details
PROGUANIL HYDROCHLORIDE
Proguanil hydrochloride
Proguanil Hydrochloride (BP/USP/Ph....
Issue/Submission Date
2005-02-06
2018-02-28
2016-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
QUETIAPINE FUMARATE
Issue/Submission Date
2007-10-25
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-0031
Status
Valid - 2019-06-05
Filing Details
Quetiapine Fumarate (IP
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0031
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-05
Filing Details
QUETIAPINE FUMARATE
Quetiapine Fumarate (IP
Issue/Submission Date
2007-10-25
2016-06-08
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-0030
Status
Valid - 2019-06-05
Filing Details
Raltegravir Potassium (IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Raltegravir Potassium (IH)
Issue/Submission Date
2016-06-23
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
RISEDRONATE SODIUM
Issue/Submission Date
2005-09-25
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RISEDRONATE SODIUM
Issue/Submission Date
2005-09-25
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
SIBUTRAMINE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2006-09-04
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
SIBUTRAMINE HYDROCHLORIDE MONOHYDRA...
Issue/Submission Date
2006-09-04
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-0030
Status
Valid - 2019-06-05
Filing Details
Simvastatin (Ph. Eur/IP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Simvastatin (Ph. Eur/IP/USP)
Issue/Submission Date
2016-06-23
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-0030
Status
Valid - 2019-06-05
Filing Details
Sitagliptin Phosphate (IP/IH)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Sitagliptin Phosphate (IP/IH)
Issue/Submission Date
2016-06-23
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
BOC COR SUCCINATE (INTERMEDIATE)
Issue/Submission Date
2007-07-15
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 - N/A
 
Filing Details
BOC COR SUCCINATE (INTERMEDIATE)
Issue/Submission Date
2007-07-15
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
SULPHAZINE
Issue/Submission Date
2003-09-03
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 - N/A
 
Filing Details
SULPHAZINE
Issue/Submission Date
2003-09-03
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-0030
Status
Valid - 2019-06-05
Filing Details
Sumatriptan (IP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
 
Valid - 2019-06-05
Filing Details
Sumatriptan (IP)
Issue/Submission Date
2016-06-23
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
SUMATRIPTAN SUCCINATE AND SUMATRIPT...
Issue/Submission Date
2010-03-10
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
Indian CDSCO WC-0030
Status
Valid - 2019-06-05
Filing Details
Sumatriptan Succinate (Ph. Eur/BP/I...
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0030
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
SUMATRIPTAN SUCCINATE AND SUMATRIPT...
Sumatriptan Succinate (Ph. Eur/BP/I...
Issue/Submission Date
2010-03-10
2016-06-23
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
TAMSULOSIN HYDROCHLORIDE
Issue/Submission Date
2005-11-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info