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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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01 ALBUTEROL SULFATE (UNMICRONIZED) (1)

02 AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE (1)

03 ATROPINE (1)

04 ATROPINE METHYLNITRATE (1)

05 ATROPINE SULFATE (1)

06 BROMPHENIRAMINE MALEATE (1)

07 CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES (1)

08 CALCIUM POLYCARBOPHIL (1)

09 CAMPTOTHECIN (1)

10 CHLORAMPHENICOL (2)

11 CHLORTHALIDONE U.S.P. (1)

12 COPOLYMERS OF TRIMETHYLENE CARBONATE WITHL- OR D,L-LACTIDE (1)

13 CROTAMITON (2)

14 DEXRAZOXANE (1)

15 DIGOXIN (1)

16 DIGOXIN 20 MICROMETER (1)

17 DIHYDROERGOTAMINE MESYLATE (1)

18 DIHYDROERGOTOXINE METHANESULFONATE (DEMS) (1)

19 DIPYRIDAMOLE (2)

20 DOXAPRAM HYDROCHLORIDE (1)

21 EPINASTINE HYDROCHLORIDE (1)

22 EPINEPHRINE (1)

23 EPINEPHRINE HYDROGENTARTRATE (1)

24 ERGOTAMINE TARTRATE (1)

25 ESERETHOL (1)

26 ESMOLOL HCL (1)

27 FENTANYL BASE (1)

28 FENTANYL CITRATE (1)

29 GLYCOPYRROLATE (1)

30 GUAIFENESIN (1)

31 GUAIFENESIN USP (1)

32 HOMATROPINE HYDROBROMIDE (1)

33 HOMATROPINE METHYLBROMIDE (1)

34 HYOSCYAMINE SULFATE (1)

35 IFN-OMEGA (1)

36 INTERLEUKIN-12 BULK SUBSTANCE (1)

37 IPRATROPIUM BROMIDE MONOHYDRATE (1)

38 ISOETHARINE HYDROCHLORIDE (1)

39 ISOPROTERENOL HYDROCHLORIDE (1)

40 KETOPROFEN (1)

41 LANTHANUM CARBONATE HYDRATE (1)

42 LEVO-ALPHA-ACETYL-METHADOL (LAAM) HYDROCHLORIDE (1)

43 LOBELINE SULFATE (1)

44 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES (1)

45 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RIDGEFIELD, CONNECTICUT. (1)

46 MELOXICAM (1)

47 MELOXICAM JETMILLED (1)

48 METAXALONE (1)

49 METHADONE HYDROCHLORIDE USP (1)

50 METHOCARBAMOL (2)

51 METHSCOPOLAMINE BROMIDE (1)

52 METHSCOPOLAMINE NITRATE (1)

53 METHYLPHENIDATE HYDROCHLORIDE (1)

54 METOCLOPRAMIDE (1)

55 MILRINONE (1)

56 MOXONIDINE (1)

57 NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB FRAGMENT (NOFETUMOMAB) AND PHENTHIOATE LIGAND BULK MATERIAL FOR ONCOTRAC KIT (NEORX) (1)

58 PHENYLEPHRINE HYDROCHLORIDE (1)

59 PHENYLEPHRINE HYDROCHLORIDE 150 MESH (1)

60 PHYSOSTIGMINE SALICYLATE (1)

61 PHYSOSTIGMINE SALICYLATE (SYNTHETIC (1)

62 PILOCARPINE HYDROCHLORIDE (1)

63 POLY(D,L-LACTIDE) AND ITS COPOLYMERS (1)

64 POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50 (1)

65 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (1)

66 PRODUCTION AND DISTRIBUTION FACILITY IN DANBURY, CONNECTICUT (1)

67 RANITIDINE HYDROCHLORIDE USP (1)

68 REPAGLINIDE (1)

69 RIBAVIRIN (1)

70 SCOPOLAMINE (1)

71 SCOPOLAMINE (HYOSCINE) (1)

72 SCOPOLAMINE AMINOXIDE HYDROBROMIDE (1)

73 SCOPOLAMINE HYDROBROMIDE (1)

74 SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN) (1)

75 THEOPHYLLINE MONOHYDRATE (1)

76 THEOPHYLLINE, ANHYDROUS (1)

77 TIOTROPIUM BROMIDE MONOHYDRATE (2)

78 TROSPIUM CHLORIDE (1)

79 YOHIMBINE HYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT (1)

80 ZOLPIDEM TARTRATE (1)

81 rTNF-alpha Drug Substance (1)

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01 AGC PHARMA CHEMICALS EUROPE SLU (1)

02 BI CHEMICALS INC (1)

03 BIDACHEM SPA (7)

04 BOEHRINGER INGELHEIM CHEMICALS INC (19)

05 BOEHRINGER INGELHEIM ESPANA SA (1)

06 BOEHRINGER INGELHEIM LABSO CHIMIE FINE (1)

07 BOEHRINGER INGELHEIM LTD (1)

08 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG (34)

09 BOEHRINGER INGELHEIM PHARMA KG (16)

10 BOEHRINGER INGELHEIM PHARMACEUTICALS INC (2)

11 BOEHRINGER INGELHEIM RCV GMBH AND CO KG (1)

12 PHILIPS ROXANE INC (1)

13 ROXANE LABORATORIES INC (1)

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01 France (1)

02 Germany (76)

03 Italy (7)

04 U.S.A (2)

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01 Active (8)

02 Inactive (78)

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01 Blank (86)

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BOEHRINGER INGELHEIM ...
Active
14258
N/A
1999-06-25
II
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BOEHRINGER INGELHEIM ...
Inactive
2314
N/A
1974-08-08
II
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BOEHRINGER INGELHEIM ...
Inactive
5791
N/A
1985-03-27
II
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BOEHRINGER INGELHEIM ...
Inactive
7334
N/A
1988-02-09
II
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BOEHRINGER INGELHEIM ...
Inactive
5494
N/A
1984-01-11
II
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BOEHRINGER INGELHEIM ...
Inactive
6024
N/A
1985-09-16
II
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BOEHRINGER INGELHEIM ...
Inactive
5753
N/A
1954-03-27
II
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BOEHRINGER INGELHEIM ...
Inactive
5980
N/A
1985-08-27
II
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BOEHRINGER INGELHEIM ...
Inactive
11714
N/A
1995-10-18
II
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