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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Boehringer Ingelheim Gmbh to the U.S. FDA. Original Data : FDA Website

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ALBUTEROL SULFATE (UNMICRONIZED)

AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE

ATROPINE

ATROPINE METHYLNITRATE

ATROPINE SULFATE

BROMPHENIRAMINE MALEATE

CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES

CALCIUM POLYCARBOPHIL

CAMPTOTHECIN

CHLORAMPHENICOL

CHLORTHALIDONE U.S.P.

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

CROTAMITON

DEXRAZOXANE

DIGOXIN

DIGOXIN 20 MICROMETER

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTOXINE METHANESULFONATE (DEMS)

DIPYRIDAMOLE

DOXAPRAM HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

EPINEPHRINE

EPINEPHRINE HYDROGENTARTRATE

ERGOTAMINE TARTRATE

ESERETHOL

ESMOLOL HCL

FENTANYL BASE

FENTANYL CITRATE

GLYCOPYRROLATE

GUAIFENESIN

GUAIFENESIN USP

HOMATROPINE HYDROBROMIDE

HOMATROPINE METHYLBROMIDE

HYOSCYAMINE SULFATE

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

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

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

RANITIDINE HYDROCHLORIDE USP

REPAGLINIDE

RIBAVIRIN

SCOPOLAMINE

SCOPOLAMINE (HYOSCINE)

SCOPOLAMINE AMINOXIDE HYDROBROMIDE

SCOPOLAMINE HYDROBROMIDE

SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN)

THEOPHYLLINE MONOHYDRATE

THEOPHYLLINE, ANHYDROUS

TIOTROPIUM BROMIDE MONOHYDRATE

TROSPIUM CHLORIDE

YOHIMBINE HYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT

ZOLPIDEM TARTRATE

rTNF-alpha Drug Substance

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FRANCE

GERMANY

ITALY

UNITED STATES

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Active

Inactive

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Complete

Blank

BOEHRINGER INGELHEIM PH...
Active
14258
N/A
1999-06-25
II
BOEHRINGER INGELHEIM CH...
Inactive
2314
N/A
1974-08-08
II
BOEHRINGER INGELHEIM PH...
Active
5791
Complete
2016-11-29
2016-11-18
1985-03-27
II
BOEHRINGER INGELHEIM PH...
Inactive
7334
N/A
1988-02-09
II
BOEHRINGER INGELHEIM PH...
Active
5494
Complete
2013-11-20
2013-11-12
1984-01-11
II
BOEHRINGER INGELHEIM CH...
Inactive
6024
N/A
1985-09-16
II
BOEHRINGER INGELHEIM PH...
Inactive
5753
N/A
1954-03-27
II
BOEHRINGER INGELHEIM CH...
Inactive
5980
N/A
1985-08-27
II
BOEHRINGER INGELHEIM PH...
Inactive
11714
N/A
1995-10-18
II
ROXANE LABORATORIES INC
Inactive
13579
N/A
1998-09-01
II
PHILIPS ROXANE INC
Inactive
13618
N/A
1998-09-01
II
BIDACHEM SPA
Inactive
4601
N/A
1982-06-23
II
BOEHRINGER INGELHEIM PH...
Inactive
11393
N/A
1995-03-15
II
BIDACHEM SPA
Active
15285
N/A
2001-02-08
II
BOEHRINGER INGELHEIM CH...
Inactive
15184
N/A
2000-12-07
II
BOEHRINGER INGELHEIM PH...
Inactive
6926
N/A
1987-04-06
II
BOEHRINGER INGELHEIM PH...
Active
21559
Complete
2014-03-31
2014-03-19
2008-04-15
II
BOEHRINGER INGELHEIM PH...
Active
10242
N/A
1993-04-26
II
BOEHRINGER INGELHEIM PH...
Inactive
2865
N/A
1977-02-24
II
MALGRAT PHARMA CHEMICAL...
Active
13870
N/A
1998-11-27
II
BOEHRINGER INGELHEIM LA...
Inactive
22764
N/A
2009-05-08
II
BOEHRINGER INGELHEIM CH...
Active
6114
N/A
1985-12-02
II
BOEHRINGER INGELHEIM PH...
Active
15003
N/A
2000-09-11
II
BOEHRINGER INGELHEIM PH...
Active
5822
Complete
2013-08-17
2013-08-12
1985-05-29
II
BOEHRINGER INGELHEIM PH...
Active
5779
Complete
2013-08-17
2013-08-12
1984-05-04
II
BOEHRINGER INGELHEIM PH...
Inactive
5765
N/A
1985-03-27
II
BOEHRINGER INGELHEIM LT...
Inactive
15743
N/A
2001-11-30
II
BOEHRINGER INGELHEIM CH...
Inactive
18139
N/A
2005-03-07
II
BOEHRINGER INGELHEIM CH...
Inactive
17826
N/A
2004-11-12
II
BOEHRINGER INGELHEIM CH...
Inactive
6044
N/A
1985-10-01
II
BOEHRINGER INGELHEIM CH...
Inactive
5972
N/A
1985-08-13
II
BOEHRINGER INGELHEIM CH...
Inactive
15507
N/A
2001-06-28
II
BOEHRINGER INGELHEIM PH...
Inactive
12067
N/A
1996-07-23
II
BOEHRINGER INGELHEIM PH...
Active
5441
Complete
2013-05-09
2013-04-24
1984-05-24
II
BOEHRINGER INGELHEIM PH...
Inactive
9351
N/A
1991-09-06
II
BOEHRINGER INGELHEIM PH...
Active
14259
N/A
1999-06-25
II
BOEHRINGER INGELHEIM PH...
Inactive
8901
N/A
1990-12-13
II
BIDACHEM SPA
Inactive
18148
N/A
2005-02-21
II
BOEHRINGER INGELHEIM CH...
Inactive
18786
N/A
2005-09-19
II
BOEHRINGER INGELHEIM CH...
Inactive
15038
N/A
2000-09-14
II
BOEHRINGER INGELHEIM PH...
Inactive
10586
N/A
1993-11-22
II
BIDACHEM SPA
Active
13846
N/A
1998-10-29
II
BOEHRINGER INGELHEIM PH...
Inactive
14430
N/A
1999-09-28
II
BOEHRINGER INGELHEIM CH...
Inactive
6530
N/A
1986-07-25
II
BOEHRINGER INGELHEIM CH...
Inactive
13942
N/A
1999-01-18
II
BOEHRINGER INGELHEIM CH...
Active
5954
N/A
1985-07-09
II
BIDACHEM SPA
Inactive
14906
N/A
2000-05-31
II
BOEHRINGER INGELHEIM PH...
Inactive
18069
N/A
2005-02-08
II
BOEHRINGER INGELHEIM PH...
Inactive
18294
N/A
2005-04-20
II
BOEHRINGER INGELHEIM CH...
Inactive
15485
N/A
2001-06-20
II
BOEHRINGER INGELHEIM CH...
Inactive
6070
N/A
1985-10-21
II
BOEHRINGER INGELHEIM CH...
Inactive
14023
N/A
1999-03-09
II
BOEHRINGER INGELHEIM PH...
Inactive
12863
N/A
1998-02-13
II
BOEHRINGER INGELHEIM PH...
Active
5912
Complete
2013-08-17
2013-08-12
1985-05-15
II
BOEHRINGER INGELHEIM PH...
Inactive
23007
N/A
2009-08-03
II
BOEHRINGER INGELHEIM PH...
Inactive
6527
N/A
1986-07-24
II
BOEHRINGER INGELHEIM PH...
Inactive
9332
N/A
1991-09-05
II
BOEHRINGER INGELHEIM PH...
Inactive
12983
N/A
1998-04-27
II
BOEHRINGER INGELHEIM PH...
Active
21413
N/A
2008-03-12
II
BOEHRINGER INGELHEIM CH...
Inactive
11480
N/A
1995-04-28
II
BOEHRINGER INGELHEIM PH...
Active
19620
N/A
2006-07-24
II
BIDACHEM SPA
Active
15756
Complete
2014-05-26
2014-05-20
2001-10-01
II
BOEHRINGER INGELHEIM PH...
Inactive
8723
N/A
1990-08-31
II
BOEHRINGER INGELHEIM PH...
Inactive
19774
N/A
2006-09-14
II
BOEHRINGER INGELHEIM PH...
Inactive
3622
N/A
1979-08-23
II
BOEHRINGER INGELHEIM PH...
Inactive
6152
N/A
1983-02-15
II
BOEHRINGER INGELHEIM PH...
Inactive
11679
N/A
1995-09-20
II
BOEHRINGER INGELHEIM PH...
Inactive
7301
N/A
1988-01-06
II
BOEHRINGER INGELHEIM PH...
Inactive
3942
N/A
1980-08-29
II
BOEHRINGER INGELHEIM PH...
Active
21939
N/A
2008-09-05
II
BOEHRINGER INGELHEIM PH...
Inactive
18135
N/A
2005-03-03
II
BOEHRINGER INGELHEIM PH...
Inactive
14967
N/A
2000-07-20
II
BOEHRINGER INGELHEIM PH...
Inactive
5376
N/A
1984-05-24
II
BOEHRINGER INGELHEIM PH...
Inactive
16940
N/A
2003-10-31
II

COPOLYMERS OF TRIMETHYLENE CARBONAT...

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
12164
N/A
1996-09-24
II

ESERETHOL

Contact the Supplier
BOEHRINGER INGELHEIM ES...
Inactive
12240
N/A
1996-11-20
II

IFN-OMEGA

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
16524
N/A
2003-04-07
II

INTERLEUKIN-12 BULK SUBSTANCE

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
18637
N/A
1995-02-23
II

MANUFACTURING SITE, FACILITIES, PER...

Contact the Supplier
BIDACHEM SPA
Inactive
3878
N/A
1980-06-18
II

NR-LU-10 MURINE MONOCLONAL ANTIBODY...

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
18617
N/A
1993-04-01
II

PHYSOSTIGMINE SALICYLATE (SYNTHETIC

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
8685
N/A
1990-07-17
II

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

Contact the Supplier
BOEHRINGER INGELHEIM PH...
Inactive
8752
N/A
1990-09-17
II

rTNF-alpha Drug Substance

Contact the Supplier
BOEHRINGER INGELHEIM RC...
Inactive
21057
N/A
2007-11-19
II

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