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

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01 99M-TC-MURINE MONOCLONAL ANTIBODY (FAB') (T2G1S) TO HUMAN FIBRIN II (B-CHAIN) (1)

02 ALFENTANIL HYDROCHLORIDE (1)

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

04 ASTEMIZOLE-R 43512 (1)

05 AZAPERONE (1)

06 BUPRENORPHINE BASE (1)

07 BUPRENORPHINE BASE DRUG SUBSTANCE (1)

08 BUTORPHANOL TARTRATE (1)

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

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

11 CARISBAMAT (RWJ 333369) (1)

12 CARNIDAZOLE (1)

13 CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE (1)

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

15 CISAPRIDE(R051619) DRUG SUBSTANCE (1)

16 CLAZURIL - R 62690 (1)

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

18 DAPOXETINE HYDROCHLORIDE (1)

19 DARUNAVIR (R319064) DRUG SUBSTANCE (1)

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

21 DRAFLAZINE (1)

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

23 EDRECOLOMAB [MURINE MONOCLONAL ANTIBODY (17-1A) TO COLORECTAL CARCINOMA] (1)

24 ETOMIDATE (1)

25 ETRAVIRINE (R165335) DRUG SUBSTANCE (1)

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

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

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

29 FIBLAST TRAFERMIN FOR INJECTION (RECOMBINANT HUMAN BASIC FIBROBLAST GROWTH FACTOR, RHBFGF) (1)

30 GALANTAMINE HYDROBROMIDE (1)

31 GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC) (1)

32 HALOPERIDOL (R001625) DRUG SUBSTANCE (1)

33 HALOPERIDOL DECANOATE (1)

34 HUMAN-MURINE CHIMERIC MONOCLONAL ANTIBODY TO TUMOR NECROSIS FACTOR FOR SEPSIS (CENTOCOR) (1)

35 INTERMEDIATE T000015 (1)

36 INTERMEDIATE T000034 (1)

37 INTERMEDIATE T000263 (1)

38 INTERMEDIATE T000425 (1)

39 INTERMEDIATE T000506 (1)

40 INTERMEDIATE T000509 (1)

41 INTERMEDIATE T000743 (1)

42 INTERMEDIATE T000824 (1)

43 INTERMEDIATE T001001 (1)

44 INTERMEDIATE T001168 (1)

45 INTERMEDIATE T001310 (1)

46 INTERMEDIATE T001330 (1)

47 INTERMEDIATE T001333 (1)

48 INTERMEDIATE T001349 (1)

49 INTERMEDIATES OF KETOCONAZOLE (1)

50 ITRACONAZOLE (R051211) DRUG SUBSTANCE (1)

51 KETOCONAZOLE DRUG SUBSTANCE (1)

52 LEVAMISOLE DRUG SUBSTANCE (1)

53 LEVAMISOLE HCL-R 12564 (1)

54 LEVAMISOLE HYDROCHLORIDE CRUDE (1)

55 LEVOCABASTINE HCL.(BULK) (1)

56 LIAROZOLE FUMERATE DRUG SUBSTANCE (1)

57 LOPERAMIDE HYDROCHLORIDE (1)

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

59 LOVIRIDE DRUG SUBSTANCE (1)

60 LUBELUZOLE (1)

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

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

63 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN STOUFFVILLE, ONTARIO, CANADA. (1)

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

65 MEBENDAZOLE POLYMORH C (1)

66 MEBENDAZOLE POLYMORPH B DRUG SUBSTANCE (1)

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

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

69 MICONAZOLE DRUG SUBSTANCE (1)

70 MICONAZOLE NITRATE DRUG SUBSTANCE (1)

71 NALMEFENE HYDROCHLORIDE (1)

72 NALOXONE HYDROCHLORIDE (1)

73 NALTREXONE BENZOATE (1)

74 NASAL NICOTINE SOLUTION (NNS) (1)

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

76 NICORETTE (1)

77 NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT (1)

78 NICOTINE OROMUCOSAL SPRAY (1)

79 NICOTINE POLACRILEX LOZENGE (1)

80 NICOTINE PURIFICATION PROCESS (1)

81 NICOTINE RESIN COMPLEX 20% (1)

82 OXATOMIDE TABLETS 30 MG (1)

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

84 PALIPERIDONE (R076477) DRUG SUBSTANCE (1)

85 PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE (1)

86 PIMOZIDE (1)

87 R093877 (1)

88 R108512 DRUG SUBSTANCE (1)

89 RIDOGREL DRUG SUBSTANCE (1)

90 RILPIVIRINE DRUG SUBSTANCE (1)

91 RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTION (1)

92 RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE (1)

93 RISPERIDONE (R064766) DRUG SUBSTANCE (1)

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

95 RIVAROXABAN 10 MG FILM COATED TABLETS (1)

96 SIMEPREVIR (R494617) DRUG SUBSTANCE (1)

97 SUFENTANIL CITRATE (1)

98 TELAPREVIR DRUG SUBSTANCE (R600109) (1)

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

100 TERCONAZOLE (PRODUCT # R42470) (1)

101 TIPIFARNIB (R115777) DRUG SUBSTANCE (1)

102 TOPIRAMATE DRUG SUBSTANCE (1)

103 TRABECTEDIN (R279741) (1)

104 VOROZOLE DRUG SUBSTANCE (1)

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01 BASILEA PHARMACEUTICA INTERNATIONAL LTD (1)

02 CENTOCOR INC (3)

03 EXTAL PTY LTD DIV JOHNSON AND JOHNSON (1)

04 JANSSEN ORTHO LLC (1)

05 JANSSEN PHARMACEUTICA NV (77)

06 JANSSEN RESEARCH AND DEVELOPMENT LLC (3)

07 JANSSEN RESEARCH FDN (2)

08 JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV (4)

09 KURA ONCOLOGY INC (1)

10 MCNEIL CONSUMER HEALTHCARE (1)

11 MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC INC (2)

12 MCNEIL PHARMACEUTICAL LTD (1)

13 SCIOS INC (1)

14 SK LIFE SCIENCE INC (1)

15 TASMANIAN ALKALOIDS PROPRIETARY LTD (2)

16 TASMANIAN ALKALOIDS PTY LTD (3)

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01 Australia (5)

02 Belgium (78)

03 Germany (4)

04 U.S.A (17)

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01 Active (25)

02 Inactive (79)

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01 Complete (3)

02 Blank (101)

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JANSSEN PHARMACEUTICA...
Inactive
11337
N/A
1995-02-03
II
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JANSSEN PHARMACEUTICA...
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5637
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1984-12-14
II
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JANSSEN PHARMACEUTICA...
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5172
N/A
1983-11-25
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JANSSEN PHARMACEUTICA...
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10859
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1994-04-08
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TASMANIAN ALKALOIDS P...
Inactive
11860
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1996-02-19
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TASMANIAN ALKALOIDS P...
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15126
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2000-11-02
II
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TASMANIAN ALKALOIDS P...
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12119
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1996-09-03
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JANSSEN PHARMACEUTICA...
Inactive
5615
N/A
1984-10-24
II
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JANSSEN PHARMACEUTICA...
Inactive
5630
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1984-11-21
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SK LIFE SCIENCE INC
Inactive
22019
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2008-10-22
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