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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Johnson & Johnson Innovative Medicine to the U.S. FDA. Original Data : FDA Website

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01 ALFENTANIL HYDROCHLORIDE (1)

02 ALTANSERIN TARTRATE (CODE NO. R 53200) (1)

03 ASTEMIZOLE-R 43512 (1)

04 AZAPERONE (1)

05 CARFENTANIL CITRATE (CODE NO. 33799) (1)

06 CARFENTANIL INJECTION 3MG./ML. (1)

07 CARISBAMAT (RWJ 333369) (1)

08 CARNIDAZOLE (1)

09 CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE (1)

10 CHEMICAL PRODUCTION & CONTROL OF BPC'S FOR INVESTIGATIONAL USE IN BEERSE, BELGIUM. (1)

11 CISAPRIDE(R051619) DRUG SUBSTANCE (1)

12 CLAZURIL - R 62690 (1)

13 CLAZURIL TABLETS 2.5 MG (R 62690) (1)

14 DAPOXETINE HYDROCHLORIDE (1)

15 DARUNAVIR (R319064) DRUG SUBSTANCE (1)

16 DOMPERIDONE (RESEARCH CODE R-33812) (1)

17 DRAFLAZINE (1)

18 DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES (1)

19 ETOMIDATE (1)

20 ETRAVIRINE (R165335) DRUG SUBSTANCE (1)

21 FACILITIES AND OPERATING PROCEDURES IN THE CHEMICAL PILOT PLANT, BEERSE, BELGIUM (1)

22 FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM. (1)

23 FACILS. & CONTROLS FOR PRODUCTION UNIT II AT GEEL, BELGIUM (1)

24 GALANTAMINE HYDROBROMIDE (1)

25 GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC) (1)

26 HALOPERIDOL (R001625) DRUG SUBSTANCE (1)

27 HALOPERIDOL DECANOATE (1)

28 INTERMEDIATE T000015 (1)

29 INTERMEDIATE T000034 (1)

30 INTERMEDIATE T000263 (1)

31 INTERMEDIATE T000425 (1)

32 INTERMEDIATE T000506 (1)

33 INTERMEDIATE T000509 (1)

34 INTERMEDIATE T000743 (1)

35 INTERMEDIATE T000824 (1)

36 INTERMEDIATE T001001 (1)

37 INTERMEDIATE T001168 (1)

38 INTERMEDIATE T001310 (1)

39 INTERMEDIATE T001330 (1)

40 INTERMEDIATE T001333 (1)

41 INTERMEDIATE T001349 (1)

42 INTERMEDIATES OF KETOCONAZOLE (1)

43 ITRACONAZOLE (R051211) DRUG SUBSTANCE (1)

44 KETOCONAZOLE DRUG SUBSTANCE (1)

45 LEVAMISOLE DRUG SUBSTANCE (1)

46 LEVAMISOLE HCL-R 12564 (1)

47 LEVAMISOLE HYDROCHLORIDE CRUDE (1)

48 LEVOCABASTINE HCL.(BULK) (1)

49 LIAROZOLE FUMERATE DRUG SUBSTANCE (1)

50 LOPERAMIDE HYDROCHLORIDE (1)

51 LORCAINIDE HCL (JANSSEN CODE NO.R 15889 (1)

52 LOVIRIDE DRUG SUBSTANCE (1)

53 LUBELUZOLE (1)

54 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PHARMACEUTICAL PRODUCTION UNIT, BEERSE, BELGIUM. (1)

55 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OLEN, BELGIUM. (1)

56 MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT GEEL, BELGIUM. (1)

57 MEBENDAZOLE POLYMORH C (1)

58 MEBENDAZOLE POLYMORPH B DRUG SUBSTANCE (1)

59 METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I) (1)

60 METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II) (1)

61 MICONAZOLE DRUG SUBSTANCE (1)

62 MICONAZOLE NITRATE DRUG SUBSTANCE (1)

63 NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS (1)

64 OXATOMIDE TABLETS 30 MG (1)

65 OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY (1)

66 PALIPERIDONE (R076477) DRUG SUBSTANCE (1)

67 PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE (1)

68 PIMOZIDE (1)

69 R093877 (1)

70 R108512 DRUG SUBSTANCE (1)

71 RIDOGREL DRUG SUBSTANCE (1)

72 RILPIVIRINE DRUG SUBSTANCE (1)

73 RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTION (1)

74 RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE (1)

75 RISPERIDONE (R064766) DRUG SUBSTANCE (1)

76 RITANSERIN (CODE NO. R 55667 ) (1)

77 RIVAROXABAN 10 MG FILM COATED TABLETS (1)

78 SIMEPREVIR (R494617) DRUG SUBSTANCE (1)

79 SUFENTANIL CITRATE (1)

80 TELAPREVIR DRUG SUBSTANCE (R600109) (1)

81 TELAPREVIR SPRAY DRIED DISPERSION (INTERMEDIATE DRUG PRODUCT) (1)

82 TERCONAZOLE (PRODUCT # R42470) (1)

83 TIPIFARNIB (R115777) DRUG SUBSTANCE (1)

84 TOPIRAMATE DRUG SUBSTANCE (1)

85 TRABECTEDIN (R279741) (1)

86 VOROZOLE DRUG SUBSTANCE (1)

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01 BASILEA PHARMACEUTICA INTERNATIONAL LTD (1)

02 JANSSEN ORTHO LLC (1)

03 JANSSEN PHARMACEUTICA NV (77)

04 JANSSEN RESEARCH AND DEVELOPMENT LLC (3)

05 JANSSEN RESEARCH FDN (2)

06 KURA ONCOLOGY INC (1)

07 SK LIFE SCIENCE INC (1)

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01 Belgium (78)

02 U.S.A (8)

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01 Active (21)

02 Inactive (65)

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01 Complete (3)

02 Blank (83)

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JANSSEN PHARMACEUTICA...
Inactive
11337
N/A
1995-02-03
II
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JANSSEN PHARMACEUTICA...
Inactive
5637
N/A
1984-12-14
II
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JANSSEN PHARMACEUTICA...
Inactive
5172
N/A
1983-11-25
II
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JANSSEN PHARMACEUTICA...
Inactive
10859
N/A
1994-04-08
II
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JANSSEN PHARMACEUTICA...
Inactive
5615
N/A
1984-10-24
II
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JANSSEN PHARMACEUTICA...
Inactive
5630
N/A
1984-11-21
II
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SK LIFE SCIENCE INC
Inactive
22019
N/A
2008-10-22
II
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JANSSEN PHARMACEUTICA...
Inactive
6107
N/A
1985-09-25
II
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BASILEA PHARMACEUTICA...
Inactive
20446
N/A
2007-05-03
II
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JANSSEN PHARMACEUTICA...
Inactive
11768
N/A
1995-12-07
II
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