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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Arch Pharmalabs Limited

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(DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL BENZENE BUTANAMIDE

3-2- CHLOROPHENYL-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE ( CMIC CHLORIDE)

3-PHENYL-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (PMIC CHLORIDE)

AMLODIPINE BESYLATE USP

ATORVASTATIN CALCIUM CRYSTALLINE

ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR)

ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4-ACETATE

ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6-{2[2-(4-FLUOROPHENYL)-5-(1-METHYLETHYL)-3-PHENYL-4[(PHENYLAMINO) CARBONYL]-1 H-PYRROL-1-YL]ETHYL}-2,2-DIMETHYL-1,3-DIOXAN-4-ACETATE

Aceclofenac

BENZTROPINE MESYLATE USP

CETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP

CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE USP (CYANO ROUTE)

CLOPIDOGREL BISULFATE (USP - XXVIII)

CLOPIDOGREL BISULFATE USP

CLOPIDOGREL BISULFATE USP (FORM-I)

CLOPIDOGREL CAMPHOR SULPHONATE SALT

Cetrizine Dihydrochloride (BP/EP)

DICMIC CHLORIDE

DOCETAXEL ANHYDROUS USP

DOCETAXEL TRIHYDRATE USP

Diclofenac sodium

EFAVIRENZ

ENTACAPONE

ESCITALOPRAM OXALATE

Ephedrine HCI

FCMIC CHLORIDE

GEMCITABINE HYDROCHLORIDE USP

GEMCITABINE HYDROCHLORIDE USP (CODE: GMI)

IBUPROFEN

IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP

LAMIVUDINE USP

MEFENAMIC ACID USP ( PRODUCT CODE : 05P)

MEFENAMIC ACID, USP

MELOXICAM USP

NEVIRAPINE ANHYDROUS USP

PACLITAXEL USP (SEMI-SYNTHETIC)

PIROXICAM USP

Perindopril tert-butylamine

Psuedoephedrine HCI

Ramipril

Ropinirole Hydrochloride

STAVUDINE USP

TRANDOLAPRIL EP

TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE

URSODIOL USP

ZIDOVUDINE USP

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Status - Active

Status - Inactive

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SUSPENDED

VALID

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221MF10166

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WC-0058

WC-0221

WC-254

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL...
Issue/Submission Date
2011-01-12
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
ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL...
Issue/Submission Date
2011-01-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
3-2- CHLOROPHENYL-5-METHYL ISOXAZOL...
Issue/Submission Date
2004-09-15
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
3-2- CHLOROPHENYL-5-METHYL ISOXAZOL...
Issue/Submission Date
2004-09-15
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
Aceclofenac
Issue/Submission Date
2014-04-15
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
Aceclofenac
Issue/Submission Date
2014-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMLODIPINE BESYLATE USP
Issue/Submission Date
2010-05-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amlodipine besilate
Issue/Submission Date
2018-03-29
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-254
Status
Expired - 2016-07-02
Filing Details
Amlodipine Besylate (BP/EP)
Issue/Submission Date
2013-08-12
Supporting Info
Application Number
Indian CDSCO WC-254
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Expired - 2016-07-02
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine besilate
Amlodipine Besylate (BP/EP)
Issue/Submission Date
2010-05-21
2018-03-29
2013-08-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6...
Issue/Submission Date
2011-05-09
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
ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6...
Issue/Submission Date
2011-05-09
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM CRYSTALLINE
Issue/Submission Date
2008-09-15
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
ATORVASTATIN CALCIUM CRYSTALLINE
Issue/Submission Date
2008-09-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM CRYSTALLINE US...
Issue/Submission Date
2010-12-01
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATORVASTATIN CALCIUM CRYSTALLINE US...
Issue/Submission Date
2010-12-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BENZTROPINE MESYLATE USP
Issue/Submission Date
2010-06-04
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
BENZTROPINE MESYLATE USP
Issue/Submission Date
2010-06-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CETIRIZINE HYDROCHLORIDE DIHYDROCHL...
Issue/Submission Date
2007-05-17
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CETIRIZINE HYDROCHLORIDE DIHYDROCHL...
Issue/Submission Date
2007-05-17
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-254
Status
Expired - 2016-07-02
Filing Details
Cetrizine Dihydrochloride (BP/EP)
Issue/Submission Date
2013-08-12
Supporting Info
Application Number
Indian CDSCO WC-254
Status
 
Expired - 2016-07-02
Filing Details
Cetrizine Dihydrochloride (BP/EP)
Issue/Submission Date
2013-08-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CITALOPRAM HYDROBROMIDE
Issue/Submission Date
2002-07-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CITALOPRAM HYDROBROMIDE
Issue/Submission Date
2002-07-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CITALOPRAM HYDROBROMIDE USP (CYANO ...
Issue/Submission Date
2010-03-03
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
CITALOPRAM HYDROBROMIDE USP (CYANO ...
Issue/Submission Date
2010-03-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOPIDOGREL BISULFATE (USP - XXVIII...
Issue/Submission Date
2005-10-27
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
CLOPIDOGREL BISULFATE (USP - XXVIII...
Issue/Submission Date
2005-10-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOPIDOGREL BISULFATE USP
Issue/Submission Date
2006-09-05
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 - N/A
 
Filing Details
CLOPIDOGREL BISULFATE USP
Issue/Submission Date
2006-09-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOPIDOGREL BISULFATE USP (FORM-I)
Issue/Submission Date
2007-04-14
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CLOPIDOGREL BISULFATE USP (FORM-I)
Issue/Submission Date
2007-04-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOPIDOGREL CAMPHOR SULPHONATE SALT
Issue/Submission Date
2011-11-19
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CLOPIDOGREL CAMPHOR SULPHONATE SALT
Issue/Submission Date
2011-11-19
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
Diclofenac sodium
Issue/Submission Date
2014-10-17
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-254
Status
Expired - 2016-07-02
Filing Details
Diclofenace Sodium (EP/BP)
Issue/Submission Date
2013-08-12
Supporting Info
Application Number
Indian CDSCO WC-254
Status
VALID
 
Expired - 2016-07-02
Filing Details
Diclofenac sodium
Diclofenace Sodium (EP/BP)
Issue/Submission Date
2014-10-17
2013-08-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOCETAXEL TRIHYDRATE USP
Issue/Submission Date
2011-09-05
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DOCETAXEL TRIHYDRATE USP
Issue/Submission Date
2011-09-05
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOCETAXEL ANHYDROUS USP
Issue/Submission Date
2011-08-20
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
DOCETAXEL ANHYDROUS USP
Issue/Submission Date
2011-08-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
EFAVIRENZ
Issue/Submission Date
2008-06-19
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
EFAVIRENZ
Issue/Submission Date
2008-06-19
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENTACAPONE
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ENTACAPONE
Issue/Submission Date
2009-03-25
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-0221
Status
Expired - 2016-07-02
Filing Details
Ephedrine HCI
Issue/Submission Date
2013-07-31
Supporting Info
Application Number
Indian CDSCO WC-0221
Status
 
Expired - 2016-07-02
Filing Details
Ephedrine HCI
Issue/Submission Date
2013-07-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESCITALOPRAM OXALATE
Issue/Submission Date
2006-06-20
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESCITALOPRAM OXALATE
Issue/Submission Date
2006-06-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2010-03-31
Supporting Info
CEP/COS

Application Number
Status
SUSPENDED
Filing Details
Gemcitabine hydrochloride Product c...
Issue/Submission Date
2014-04-25
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 - N/A
SUSPENDED
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride Product c...
Issue/Submission Date
2010-03-31
2014-04-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GEMCITABINE HYDROCHLORIDE USP (CODE...
Issue/Submission Date
2010-05-26
Supporting Info
CEP/COS

Application Number
Status
SUSPENDED
Filing Details
Gemcitabine hydrochloride Product c...
Issue/Submission Date
2014-04-25
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 - N/A
SUSPENDED
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (CODE...
Gemcitabine hydrochloride Product c...
Issue/Submission Date
2010-05-26
2014-04-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
IBUPROFEN
Issue/Submission Date
1991-05-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ibuprofen
Issue/Submission Date
2014-04-15
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
IBUPROFEN
Ibuprofen
Issue/Submission Date
1991-05-13
2014-04-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
Issue/Submission Date
2011-05-06
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
Issue/Submission Date
2011-05-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
LAMIVUDINE USP
Issue/Submission Date
2008-04-17
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
LAMIVUDINE USP
Issue/Submission Date
2008-04-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LAMIVUDINE USP
Issue/Submission Date
2008-04-17
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lamivudine
Issue/Submission Date
2015-01-22
Supporting Info
Japanese DMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
LAMIVUDINE USP
Lamivudine
Issue/Submission Date
2008-04-17
2015-01-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MEFENAMIC ACID, USP
Issue/Submission Date
2006-02-23
Supporting Info
CEP/COS

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

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

Application Number
Indian CDSCO WC-254
Status
Expired - 2016-07-02
Filing Details
Mefenamic Acid(BP/EP)
Issue/Submission Date
2013-08-12
Supporting Info
Application Number
Indian CDSCO WC-254
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Expired - 2016-07-02
Filing Details
MEFENAMIC ACID, USP
Mefenamic Acid(BP/EP)
Issue/Submission Date
2006-02-23
2013-08-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MEFENAMIC ACID USP ( PRODUCT CODE :...
Issue/Submission Date
2015-10-12
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
MEFENAMIC ACID USP ( PRODUCT CODE :...
Issue/Submission Date
2015-10-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MELOXICAM USP
Issue/Submission Date
2002-04-05
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 - N/A
 
Filing Details
MELOXICAM USP
Issue/Submission Date
2002-04-05
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
NEVIRAPINE ANHYDROUS USP
Issue/Submission Date
2008-11-05
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NEVIRAPINE ANHYDROUS USP
Issue/Submission Date
2008-11-05
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PACLITAXEL USP (SEMI-SYNTHETIC)
Issue/Submission Date
2012-03-30
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
PACLITAXEL USP (SEMI-SYNTHETIC)
Issue/Submission Date
2012-03-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO ...
Issue/Submission Date
2011-03-11
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO ...
Issue/Submission Date
2011-03-11
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USDMF

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

Application Number
Status
VALID
Filing Details
Perindopril tert-butylamine
Issue/Submission Date
2019-01-24
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
Perindopril tert-butylamine
Issue/Submission Date
2019-01-24
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
3-PHENYL-5-METHYL ISOXAZOLE-4-CARBO...
Issue/Submission Date
2005-03-28
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
3-PHENYL-5-METHYL ISOXAZOLE-4-CARBO...
Issue/Submission Date
2005-03-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PIROXICAM USP
Issue/Submission Date
1991-05-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Piroxicam
Issue/Submission Date
2014-05-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Piroxicam at H-Wing, 4th Floor, Tex...
Issue/Submission Date
2009-07-30
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-254
Status
Expired - 2016-07-02
Filing Details
Piroxicam (BP/EP)
Issue/Submission Date
2013-08-12
Supporting Info
Application Number
Indian CDSCO WC-254
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Expired - 2016-07-02
Filing Details
PIROXICAM USP
Piroxicam
Piroxicam at H-Wing, 4th Floor, Tex...
Piroxicam (BP/EP)
Issue/Submission Date
1991-05-13
2014-05-07
2009-07-30
2013-08-12
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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
Japanese DMF

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

Application Number
Indian CDSCO WC-0221
Status
Expired - 2016-07-02
Filing Details
Psuedoephedrine HCI
Issue/Submission Date
2013-07-31
Supporting Info
Application Number
Indian CDSCO WC-0221
Status
 
Expired - 2016-07-02
Filing Details
Psuedoephedrine HCI
Issue/Submission Date
2013-07-31
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
Ramipril
Issue/Submission Date
2017-06-02
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
Ramipril
Issue/Submission Date
2017-06-02
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-0058
Status
Expired - 2016-07-02
Filing Details
Ropinirole Hydrochloride
Issue/Submission Date
2013-06-18
Supporting Info
Application Number
Indian CDSCO WC-0058
Status
 
Expired - 2016-07-02
Filing Details
Ropinirole Hydrochloride
Issue/Submission Date
2013-06-18
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
STAVUDINE USP
Issue/Submission Date
2008-05-12
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 - Unpaid
DMF Review - N/A
 
Filing Details
STAVUDINE USP
Issue/Submission Date
2008-05-12
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
STAVUDINE USP
Issue/Submission Date
2008-08-21
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
STAVUDINE USP
Issue/Submission Date
2008-08-21
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
TRANDOLAPRIL EP
Issue/Submission Date
2007-07-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Trandolapril
Issue/Submission Date
2015-09-03
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
TRANDOLAPRIL EP
Trandolapril
Issue/Submission Date
2007-07-13
2015-09-03
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
URSODIOL USP
Issue/Submission Date
2018-12-17
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
URSODIOL USP
Issue/Submission Date
2018-12-17
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ZIDOVUDINE USP
Issue/Submission Date
2008-02-06
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ZIDOVUDINE USP
Issue/Submission Date
2008-02-06
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZIDOVUDINE USP
Issue/Submission Date
2008-04-24
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ZIDOVUDINE USP
Issue/Submission Date
2008-04-24
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FCMIC CHLORIDE
Issue/Submission Date
2004-12-27
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
FCMIC CHLORIDE
Issue/Submission Date
2004-12-27
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICMIC CHLORIDE
Issue/Submission Date
2004-12-12
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
DICMIC CHLORIDE
Issue/Submission Date
2004-12-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
(DKT -III) 4-FLUORO- ALPHA- [2-METH...
Issue/Submission Date
2010-09-13
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details