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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dipharma Francis S.r.l.

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7-KETOLITHOCHOLIC ACID

AMINOCAPROIC ACID

AMITRIPTYLINE HYDROCHLORIDE

Apixaban

Armodafinil

Azelnidipine

BENDROFLUMETHIAZIDE USP

BUPROPION HCL

BUPROPION HYDROBROMIDE

Benazepril Hydrochloride

Bosentan

CHLORPROPAMIDE

CILOSTAZOL

CYCLOBENZAPRINE HCL

CYPROHEPTADINE HCL, USP

Cholic acid

Cinacalcet Hydrochloride

DAPSONE

DEXLANSOPRAZOLE AMORPHOUS

DEXLANSOPRAZOLE ANHYDROUS

DIBENZOSUBERENONE

DICLOFENAC POTASSIUM

DICLOFENAC SODIUM EP/USP

DOXEPIN HCl

Dextropropoxyphene hydrochloride

Diclofenac Hydroxyethylpyrrolidine

Dothiepin

EFINACONAZOLE

ENTACAPONE

FEXOFENADINE HYDROCHLORIDE USP

FEXOFENADINE HYDROCHLORIDE USP FORM A

FEXOFENADINE HYDROCHLORIDE USP FORM l

Fesoterodine

GLYBURIDE

GLYCERIN TRINITRATE (NITROGLYCERIN-NG)

GLYCERYL TRINITRATE SOLUTION

IBUPROFEN LYSINE SALT

ISOSORBIDE DINITRATE (ISDN)

ISOSORBIDE-5-MONONITRATE (5-ISMN)

Isosorbide dinitrate, diluted 25% in lactose monohydrate

Isosorbide mononitrate, diluted 80% in Lactose

Isosorbide mononitrate, diluted 90% in lactose

Linagliptin

MANDELATE SALT, INTERMEDIATE

MODAFINIL USP

Minodronic Acid monohydrate

NIFEDIPINE USP

NORTRIPTYLINE HCL

PALIPERIDONE

PIRFENIDONE

PIROXICAM

PROTRIPTYLINE HYDROCHLORIDE

Pramipexole

Pramipexole Dihydrochloride Monohydrate

Rabeprazole

Rasagiline Mesylate

Rufinamide

SELEGILINE BASE

SELEGILINE HYDROCHLORIDE

SPIRONOLACTONE

SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY

Sapropterin Dihydrochloride

TOLBUTAMIDE USP

TRAMADOL HCL

TRIAMTERENE USP

Telmisartan

Terbinafine Hydrochloride

Tolazamide

Tolterodine

URSODEOXYCHOLIC ACID

Venlafaxine hydrochloride

Vortioxetine Hydrobromide

ZONISAMIDE

Ziprasidone

Ziprasidone Hydrochloride

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Status - Inactive

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EXPIRED

VALID

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218MF10745

219MF10264

219MF10340

220MF10221

224MF10231

225MF10158

227MF10070

228MF10070

228MF10082

229MF10153

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMINOCAPROIC ACID
Issue/Submission Date
2016-12-14
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
AMINOCAPROIC ACID
Issue/Submission Date
2016-12-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMITRIPTYLINE HYDROCHLORIDE
Issue/Submission Date
1977-03-18
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amitriptyline hydrochloride
Issue/Submission Date
2015-10-28
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
VALID
 
Filing Details
AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline hydrochloride
Issue/Submission Date
1977-03-18
2015-10-28
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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

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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
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
Azelnidipine at Via Bissone, 5,2002...
Issue/Submission Date
2013-08-14
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Azelnidipine at Via Bissone, 5,2002...
Issue/Submission Date
2013-08-14
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 - N/A
Filing Details
BENDROFLUMETHIAZIDE USP
Issue/Submission Date
1986-05-09
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
BENDROFLUMETHIAZIDE USP
Issue/Submission Date
1986-05-09
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
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
BUPROPION HCL
Issue/Submission Date
1999-11-11
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 - Complete
 
Filing Details
BUPROPION HCL
Issue/Submission Date
1999-11-11
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BUPROPION HYDROBROMIDE
Issue/Submission Date
2009-04-14
Supporting Info
CEP/COS

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

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

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

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORPROPAMIDE
Issue/Submission Date
1979-03-02
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CHLORPROPAMIDE
Issue/Submission Date
1979-03-02
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
Cholic acid
Issue/Submission Date
2015-07-08
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
Cholic acid
Issue/Submission Date
2015-07-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CILOSTAZOL
Issue/Submission Date
2003-12-22
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CILOSTAZOL
Issue/Submission Date
2003-12-22
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
CYCLOBENZAPRINE HCL
Issue/Submission Date
1985-06-06
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CYCLOBENZAPRINE HCL
Issue/Submission Date
1985-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CYPROHEPTADINE HCL, USP
Issue/Submission Date
1979-02-08
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Cyproheptadine hydrochloride hydrat...
Issue/Submission Date
2008-11-04
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
CYPROHEPTADINE HCL, USP
Cyproheptadine hydrochloride hydrat...
Issue/Submission Date
1979-02-08
2008-11-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DAPSONE
Issue/Submission Date
2017-06-22
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DAPSONE
Issue/Submission Date
2017-06-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXLANSOPRAZOLE AMORPHOUS
Issue/Submission Date
2018-01-19
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DEXLANSOPRAZOLE AMORPHOUS
Issue/Submission Date
2018-01-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXLANSOPRAZOLE ANHYDROUS
Issue/Submission Date
2018-01-19
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DEXLANSOPRAZOLE ANHYDROUS
Issue/Submission Date
2018-01-19
Supporting Info
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USDMF

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

Application Number
Status
EXPIRED
Filing Details
Dextropropoxyphene hydrochloride
Issue/Submission Date
2005-11-03
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
EXPIRED
 
Filing Details
Dextropropoxyphene hydrochloride
Issue/Submission Date
2005-11-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIBENZOSUBERENONE
Issue/Submission Date
1998-10-21
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
DIBENZOSUBERENONE
Issue/Submission Date
1998-10-21
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
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC POTASSIUM
Issue/Submission Date
1998-06-26
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DICLOFENAC POTASSIUM
Issue/Submission Date
1998-06-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DICLOFENAC SODIUM EP/USP
Issue/Submission Date
1986-11-20
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 - Complete
 
Filing Details
DICLOFENAC SODIUM EP/USP
Issue/Submission Date
1986-11-20
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
DOXEPIN HCl
Issue/Submission Date
1984-04-10
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DOXEPIN HCl
Issue/Submission Date
1984-04-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EFINACONAZOLE
Issue/Submission Date
2017-08-02
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
EFINACONAZOLE
Issue/Submission Date
2017-08-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENTACAPONE
Issue/Submission Date
2009-02-17
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Entacapone at Via Bissone, 5,20021-...
Issue/Submission Date
2015-03-12
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
ENTACAPONE
Entacapone at Via Bissone, 5,20021-...
Issue/Submission Date
2009-02-17
2015-03-12
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
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FEXOFENADINE HYDROCHLORIDE USP
Issue/Submission Date
2002-06-20
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Fexofenadine hydrochloride at Via B...
Issue/Submission Date
2016-03-02
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
FEXOFENADINE HYDROCHLORIDE USP
Fexofenadine hydrochloride at Via B...
Issue/Submission Date
2002-06-20
2016-03-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FEXOFENADINE HYDROCHLORIDE USP FORM...
Issue/Submission Date
2014-06-13
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
FEXOFENADINE HYDROCHLORIDE USP FORM...
Issue/Submission Date
2014-06-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FEXOFENADINE HYDROCHLORIDE USP FORM...
Issue/Submission Date
2014-11-05
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
FEXOFENADINE HYDROCHLORIDE USP FORM...
Issue/Submission Date
2014-11-05
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MANDELATE SALT, INTERMEDIATE
Issue/Submission Date
2004-10-14
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MANDELATE SALT, INTERMEDIATE
Issue/Submission Date
2004-10-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GLYBURIDE
Issue/Submission Date
1988-09-16
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Glibenclamide at Via Bissone, 5,200...
Issue/Submission Date
2012-12-18
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Issue/Submission Date
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Application Number
Status
Status - Active
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GLYBURIDE
Glibenclamide at Via Bissone, 5,200...
Issue/Submission Date
1988-09-16
2012-12-18
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Status
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Facility Fees - Paid
DMF Review - N/A
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GLYCERYL TRINITRATE SOLUTION
Issue/Submission Date
2010-08-31
Supporting Info
CEP/COS

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Status
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Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
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Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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GLYCERYL TRINITRATE SOLUTION
Issue/Submission Date
2010-08-31
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USDMF

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Status
Status - Active
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DMF Review - N/A
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IBUPROFEN LYSINE SALT
Issue/Submission Date
2008-03-20
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
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Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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IBUPROFEN LYSINE SALT
Issue/Submission Date
2008-03-20
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Status
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Facility Fees - Paid
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ISOSORBIDE-5-MONONITRATE (5-ISMN)
Issue/Submission Date
1987-01-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isosorbide mononitrate, diluted 70%...
Issue/Submission Date
2014-08-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Isosorbide mononitrate at Via Bisso...
Issue/Submission Date
2006-09-06
Supporting Info
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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
ISOSORBIDE-5-MONONITRATE (5-ISMN)
Isosorbide mononitrate, diluted 70%...
Isosorbide mononitrate at Via Bisso...
Issue/Submission Date
1987-01-09
2014-08-26
2006-09-06
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USDMF

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Issue/Submission Date
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CEP/COS

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Status
VALID
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Isosorbide dinitrate, diluted 25% i...
Issue/Submission Date
2017-02-24
Supporting Info
Japanese DMF

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Status
 
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Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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Status
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Filing Details
Isosorbide dinitrate, diluted 25% i...
Issue/Submission Date
2017-02-24
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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ISOSORBIDE DINITRATE (ISDN)
Issue/Submission Date
1980-02-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isosorbide dinitrate, diluted 40% i...
Issue/Submission Date
2017-02-24
Supporting Info
Japanese DMF

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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
ISOSORBIDE DINITRATE (ISDN)
Isosorbide dinitrate, diluted 40% i...
Issue/Submission Date
1980-02-07
2017-02-24
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isosorbide mononitrate, diluted 80%...
Issue/Submission Date
2014-08-26
Supporting Info
Japanese DMF

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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
Isosorbide mononitrate, diluted 80%...
Issue/Submission Date
2014-08-26
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
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Isosorbide mononitrate, diluted 90%...
Issue/Submission Date
2014-09-02
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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Issue/Submission Date
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Status
VALID
 
Filing Details
Isosorbide mononitrate, diluted 90%...
Issue/Submission Date
2014-09-02
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USDMF

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Issue/Submission Date
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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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

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Supporting Info
CEP/COS

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Issue/Submission Date
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Japanese DMF

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Filing Details
Minodronic Acid monohydrate at Via ...
Issue/Submission Date
2016-04-06
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Minodronic Acid monohydrate at Via ...
Issue/Submission Date
2016-04-06
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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MODAFINIL USP
Issue/Submission Date
2002-11-19
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
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Status
Filing Details
Issue/Submission Date
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Status
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Facility Fees - Paid
DMF Review - Complete
 
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MODAFINIL USP
Issue/Submission Date
2002-11-19
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USDMF

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NIFEDIPINE USP
Issue/Submission Date
1986-07-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Nifedipine
Issue/Submission Date
2019-01-24
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
NIFEDIPINE USP
Nifedipine
Issue/Submission Date
1986-07-23
2019-01-24
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USDMF

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Status
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Facility Fees - Paid
DMF Review - Complete
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GLYCERIN TRINITRATE (NITROGLYCERIN-...
Issue/Submission Date
1980-02-07
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
GLYCERIN TRINITRATE (NITROGLYCERIN-...
Issue/Submission Date
1980-02-07
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USDMF

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NORTRIPTYLINE HCL
Issue/Submission Date
1988-12-29
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CEP/COS

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Status
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Japanese DMF

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Status
 
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Nortriptyline hydrochloride at Via ...
Issue/Submission Date
2007-08-16
Supporting Info
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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
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NORTRIPTYLINE HCL
Nortriptyline hydrochloride at Via ...
Issue/Submission Date
1988-12-29
2007-08-16
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
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USDMF

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DMF Review - Complete
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PIRFENIDONE
Issue/Submission Date
2018-04-24
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission