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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Boehringer Ingelheim Gmbh

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ALBUTEROL SULFATE (UNMICRONIZED)

AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE

ATROPINE

ATROPINE METHYLNITRATE

ATROPINE SULFATE

Ambroxol hydrochloride

BROMPHENIRAMINE MALEATE

Beperuminogen per plasmid

Bisacodyl

Bisacodyl Powder

Bromhexine hydrochloride

Brotizolam Micronised

CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES

CALCIUM POLYCARBOPHIL

CAMPTOTHECIN

CHLORAMPHENICOL

CHLORTHALIDONE U.S.P.

COPOLYMERS OF TRIMETHYLENE CARBONATE WITHL- OR D,L-LACTIDE

CROTAMITON

Clenbuterol Hydrochloride

Clonidine hydrochloride

DEXRAZOXANE

DIGOXIN

DIGOXIN 20 MICROMETER

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTOXINE METHANESULFONATE (DEMS)

DIPYRIDAMOLE

DOXAPRAM HYDROCHLORIDE

Dihydroergotamine mesilate

EPINASTINE HYDROCHLORIDE

EPINEPHRINE

EPINEPHRINE HYDROGENTARTRATE

ERGOTAMINE TARTRATE

ESERETHOL

ESMOLOL HCL

Etilefrine Hydrochloride

FENTANYL BASE

FENTANYL CITRATE

Fenoterol hydrobromide

GLYCOPYRROLATE

GUAIFENESIN

GUAIFENESIN USP

HOMATROPINE HYDROBROMIDE

HOMATROPINE METHYLBROMIDE

HYOSCYAMINE SULFATE

Hydrochloric acid doxapram

IFN-OMEGA

INTERLEUKIN-12 BULK SUBSTANCE

IPRATROPIUM BROMIDE MONOHYDRATE

ISOPROTERENOL HYDROCHLORIDE

KETOPROFEN

LANTHANUM CARBONATE HYDRATE

LEVO-ALPHA-ACETYL-METHADOL (LAAM) HYDROCHLORIDE

LOBELINE SULFATE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

MELOXICAM

MELOXICAM JETMILLED

METAXALONE

METHADONE HYDROCHLORIDE USP

METHOCARBAMOL

METHSCOPOLAMINE BROMIDE

METHSCOPOLAMINE NITRATE

METHYLPHENIDATE HYDROCHLORIDE

METOCLOPRAMIDE

MILRINONE

MOXONIDINE

Magnesium aspartate dihydrate

NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB FRAGMENT (NOFETUMOMAB) AND PHENTHIOATE LIGAND BULK MATERIAL FOR ONCOTRAC KIT (NEORX)

Orciprenaline sulfate

Orciprenaline sulfate Micronised (particle size 5 µm)

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE 150 MESH

PHYSOSTIGMINE SALICYLATE

PHYSOSTIGMINE SALICYLATE (SYNTHETIC

PILOCARPINE HYDROCHLORIDE

POLY(D,L-LACTIDE) AND ITS COPOLYMERS

POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Phenylephrine

Pulmonary surfactant

RANITIDINE HYDROCHLORIDE USP

REPAGLINIDE

RIBAVIRIN

SCOPOLAMINE

SCOPOLAMINE (HYOSCINE)

SCOPOLAMINE AMINOXIDE HYDROBROMIDE

SCOPOLAMINE HYDROBROMIDE

SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN)

Sodium picosulfate

THEOPHYLLINE MONOHYDRATE

THEOPHYLLINE, ANHYDROUS

TIOTROPIUM BROMIDE MONOHYDRATE

TROSPIUM CHLORIDE

Tramazoline hydrochloride monohydrate

YOHIMBINE HYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT

ZOLPIDEM TARTRATE

rTNF-alpha Drug Substance

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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218MF10395

218MF10482

218MF10483

218MF10495

220MF10081

220MF10085

220MF10132

221MF10015

221MF10105

221MF10127

221MF10144

222MF10278

224MF10100

230MF10030

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALBUTEROL SULFATE (UNMICRONIZED)
Issue/Submission Date
1999-06-25
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Salbutamol sulfate
Issue/Submission Date
2010-06-23
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
ALBUTEROL SULFATE (UNMICRONIZED)
Salbutamol sulfate
Issue/Submission Date
1999-06-25
2010-06-23
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
Ambroxol hydrochloride
Issue/Submission Date
2011-02-10
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ambroxol hydrochloride at S. S. 11 ...
Issue/Submission Date
2008-03-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Ambroxol hydrochloride
Ambroxol hydrochloride at S. S. 11 ...
Issue/Submission Date
2011-02-10
2008-03-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATROPINE
Issue/Submission Date
1985-03-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Atropine
Issue/Submission Date
2017-03-17
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
ATROPINE
Atropine
Issue/Submission Date
1985-03-27
2017-03-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATROPINE METHYLNITRATE
Issue/Submission Date
1988-02-09
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
ATROPINE METHYLNITRATE
Issue/Submission Date
1988-02-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATROPINE SULFATE
Issue/Submission Date
1984-01-11
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Atropine sulfate
Issue/Submission Date
2011-02-18
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Atropine sulfate at Binger Strasse ...
Issue/Submission Date
2006-05-15
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
ATROPINE SULFATE
Atropine sulfate
Atropine sulfate at Binger Strasse ...
Issue/Submission Date
1984-01-11
2011-02-18
2006-05-15
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
Bisacodyl Powder
Issue/Submission Date
2010-01-07
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
Bisacodyl Powder
Issue/Submission Date
2010-01-07
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
Bisacodyl
Issue/Submission Date
2010-01-07
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
Bisacodyl
Issue/Submission Date
2010-01-07
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
Bromhexine hydrochloride
Issue/Submission Date
2015-12-14
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
Bromhexine hydrochloride
Issue/Submission Date
2015-12-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BROMPHENIRAMINE MALEATE
Issue/Submission Date
1985-09-16
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BROMPHENIRAMINE MALEATE
Issue/Submission Date
1985-09-16
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
Brotizolam Micronised
Issue/Submission Date
2014-10-31
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
Brotizolam Micronised
Issue/Submission Date
2014-10-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CAFFEINE AS PROCESSED IN INGELHEIM ...
Issue/Submission Date
1954-03-27
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
CAFFEINE AS PROCESSED IN INGELHEIM ...
Issue/Submission Date
1954-03-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CALCIUM POLYCARBOPHIL
Issue/Submission Date
1985-08-27
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
CALCIUM POLYCARBOPHIL
Issue/Submission Date
1985-08-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CAMPTOTHECIN
Issue/Submission Date
1995-10-18
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
CAMPTOTHECIN
Issue/Submission Date
1995-10-18
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CHLORAMPHENICOL
Issue/Submission Date
1998-09-01
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CHLORAMPHENICOL
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CHLORAMPHENICOL
Issue/Submission Date
1998-09-01
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CHLORAMPHENICOL
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORTHALIDONE U.S.P.
Issue/Submission Date
1982-06-23
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CHLORTHALIDONE U.S.P.
Issue/Submission Date
1982-06-23
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
Clenbuterol Hydrochloride
Issue/Submission Date
2014-10-10
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
Clenbuterol Hydrochloride
Issue/Submission Date
2014-10-10
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
Clonidine hydrochloride
Issue/Submission Date
2009-05-14
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
Clonidine hydrochloride
Issue/Submission Date
2009-05-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CROTAMITON
Issue/Submission Date
1995-03-15
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
CROTAMITON
Issue/Submission Date
1995-03-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CROTAMITON
Issue/Submission Date
2001-02-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Crotamiton
Issue/Submission Date
2012-05-11
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Crotamiton at S. S. 11 Padana Super...
Issue/Submission Date
2009-06-23
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
CROTAMITON
Crotamiton
Crotamiton at S. S. 11 Padana Super...
Issue/Submission Date
2001-02-08
2012-05-11
2009-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEXRAZOXANE
Issue/Submission Date
2000-12-07
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
DEXRAZOXANE
Issue/Submission Date
2000-12-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIGOXIN
Issue/Submission Date
1987-04-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Digoxin
Issue/Submission Date
2015-09-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Digoxin (crystal) at Binger Strasse...
Issue/Submission Date
2010-12-17
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
DIGOXIN
Digoxin
Digoxin (crystal) at Binger Strasse...
Issue/Submission Date
1987-04-06
2015-09-25
2010-12-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DIGOXIN 20 MICROMETER
Issue/Submission Date
2008-04-15
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DIGOXIN 20 MICROMETER
Issue/Submission Date
2008-04-15
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
Dihydroergotamine mesilate
Issue/Submission Date
2015-11-03
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
VALID
 
Filing Details
Dihydroergotamine mesilate
Issue/Submission Date
2015-11-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIHYDROERGOTAMINE MESYLATE
Issue/Submission Date
1993-04-26
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
DIHYDROERGOTAMINE MESYLATE
Issue/Submission Date
1993-04-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIHYDROERGOTOXINE METHANESULFONATE ...
Issue/Submission Date
1977-02-24
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
DIHYDROERGOTOXINE METHANESULFONATE ...
Issue/Submission Date
1977-02-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DIPYRIDAMOLE
Issue/Submission Date
2009-05-08
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
DIPYRIDAMOLE
Issue/Submission Date
2009-05-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIPYRIDAMOLE
Issue/Submission Date
1998-11-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Dipyridamole
Issue/Submission Date
2009-11-12
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
DIPYRIDAMOLE
Dipyridamole
Issue/Submission Date
1998-11-27
2009-11-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DOXAPRAM HYDROCHLORIDE
Issue/Submission Date
1985-12-02
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
DOXAPRAM HYDROCHLORIDE
Issue/Submission Date
1985-12-02
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USDMF

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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Hydrochloric acid doxapram at 2820 ...
Issue/Submission Date
2006-05-15
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Written Confirmation

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Hydrochloric acid doxapram at 2820 ...
Issue/Submission Date
2006-05-15
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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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EPINEPHRINE HYDROGENTARTRATE
Issue/Submission Date
1984-05-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Adrenaline tartrate
Issue/Submission Date
2009-11-17
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Epinephrine bitartrate at Binger St...
Issue/Submission Date
2009-01-13
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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 - Complete
VALID
 
Filing Details
EPINEPHRINE HYDROGENTARTRATE
Adrenaline tartrate
Epinephrine bitartrate at Binger St...
Issue/Submission Date
1984-05-04
2009-11-17
2009-01-13
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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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EPINASTINE HYDROCHLORIDE
Issue/Submission Date
2000-09-11
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Epinastine hydrochloride
Issue/Submission Date
2018-04-26
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Japanese DMF

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Status
 
Filing Details
Epinastine hydrochloride at Binger ...
Issue/Submission Date
2012-05-23
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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
EPINASTINE HYDROCHLORIDE
Epinastine hydrochloride
Epinastine hydrochloride at Binger ...
Issue/Submission Date
2000-09-11
2018-04-26
2012-05-23
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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EPINEPHRINE
Issue/Submission Date
1985-05-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Adrenaline
Issue/Submission Date
2016-03-17
Supporting Info
Japanese DMF

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Status
 
Filing Details
Epinephrine at Binger Strasse 173, ...
Issue/Submission Date
2006-05-15
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
EPINEPHRINE
Adrenaline
Epinephrine at Binger Strasse 173, ...
Issue/Submission Date
1985-05-29
2016-03-17
2006-05-15
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ERGOTAMINE TARTRATE
Issue/Submission Date
1985-03-27
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Ergotamine Tartrate
Issue/Submission Date
2004-10-13
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
WITHDRAWN BY HOLDER
 
Filing Details
ERGOTAMINE TARTRATE
Ergotamine Tartrate
Issue/Submission Date
1985-03-27
2004-10-13
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USDMF

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ESMOLOL HCL
Issue/Submission Date
2001-11-30
Supporting Info
CEP/COS

Application Number
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
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESMOLOL HCL
Issue/Submission Date
2001-11-30
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USDMF

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

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Status
VALID
Filing Details
Etilefrine Hydrochloride
Issue/Submission Date
2006-04-26
Supporting Info
Japanese DMF

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

Application Number
Status
Filing Details
Issue/Submission Date
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Application Number
Status
VALID
 
Filing Details
Etilefrine Hydrochloride
Issue/Submission Date
2006-04-26
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USDMF

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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Fenoterol hydrobromide
Issue/Submission Date
2018-05-23
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

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Status
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Status
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Filing Details
Fenoterol hydrobromide
Issue/Submission Date
2018-05-23
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USDMF

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Status
Status - Inactive
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DMF Review - N/A
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FENTANYL BASE
Issue/Submission Date
2005-03-07
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CEP/COS

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Status
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Issue/Submission Date
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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
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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
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FENTANYL BASE
Issue/Submission Date
2005-03-07
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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FENTANYL CITRATE
Issue/Submission Date
2004-11-12
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
FENTANYL CITRATE
Issue/Submission Date
2004-11-12
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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GLYCOPYRROLATE
Issue/Submission Date
1985-10-01
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GLYCOPYRROLATE
Issue/Submission Date
1985-10-01
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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GUAIFENESIN
Issue/Submission Date
1985-08-13
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GUAIFENESIN
Issue/Submission Date
1985-08-13
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
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GUAIFENESIN USP
Issue/Submission Date
2001-06-28
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

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GUAIFENESIN USP
Issue/Submission Date
2001-06-28
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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HOMATROPINE HYDROBROMIDE
Issue/Submission Date
1996-07-23
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Homatropine Hydrobromide
Issue/Submission Date
2007-11-15
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
WITHDRAWN BY HOLDER
 
Filing Details
HOMATROPINE HYDROBROMIDE
Homatropine Hydrobromide
Issue/Submission Date
1996-07-23
2007-11-15
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
HOMATROPINE METHYLBROMIDE
Issue/Submission Date
1984-05-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Homatropine Methylbromide
Issue/Submission Date
2012-03-16
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
HOMATROPINE METHYLBROMIDE
Homatropine Methylbromide
Issue/Submission Date
1984-05-24
2012-03-16
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYOSCYAMINE SULFATE
Issue/Submission Date
1991-09-06
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Hyoscyamine sulfate
Issue/Submission Date
2007-10-05
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
WITHDRAWN BY HOLDER
 
Filing Details
HYOSCYAMINE SULFATE
Hyoscyamine sulfate
Issue/Submission Date
1991-09-06
2007-10-05
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IPRATROPIUM BROMIDE MONOHYDRATE
Issue/Submission Date
1999-06-25
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ipratropium bromide
Issue/Submission Date
2015-10-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ipratropium bromide hydrate at Bing...
Issue/Submission Date
2008-03-14
Supporting Info
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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
IPRATROPIUM BROMIDE MONOHYDRATE
Ipratropium bromide
Ipratropium bromide hydrate at Bing...
Issue/Submission Date
1999-06-25
2015-10-08
2008-03-14
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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ISOPROTERENOL HYDROCHLORIDE
Issue/Submission Date
1990-12-13
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ISOPROTERENOL HYDROCHLORIDE
Issue/Submission Date
1990-12-13
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USDMF

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Status
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DMF Review - N/A
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KETOPROFEN
Issue/Submission Date
2005-02-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ketoprofen
Issue/Submission Date
2010-07-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ketoprofen at S. S. 11 Padana Super...
Issue/Submission Date
2006-03-20
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
KETOPROFEN
Ketoprofen
Ketoprofen at S. S. 11 Padana Super...
Issue/Submission Date
2005-02-21
2010-07-08
2006-03-20
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
POLY(D,L-LACTIDE) AND ITS COPOLYMER...
Issue/Submission Date
1998-04-27
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
POLY(D,L-LACTIDE) AND ITS COPOLYMER...
Issue/Submission Date
1998-04-27
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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LANTHANUM CARBONATE HYDRATE
Issue/Submission Date
2005-09-19
Supporting Info
CEP/COS

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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
LANTHANUM CARBONATE HYDRATE
Issue/Submission Date
2005-09-19
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOBELINE SULFATE
Issue/Submission Date
1993-11-22
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LOBELINE SULFATE
Issue/Submission Date
1993-11-22
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USDMF

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Status