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

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01 6-APA (1)

02 7-ADCA (1)

03 7-AMINO CEPHALOSPORANIC ACID (7-ACA) (1)

04 AMIKACIN BASE (1)

05 AMIKACIN SULFATE (1)

06 AMOXICILLIN TRIHYDRATE (1)

07 AMPHOTERICIN B (1)

08 AMPHOTERICIN NON PARENTAL GRADE (1)

09 AMPICILLIN (1)

10 AMPICILLIN SODIUM (1)

11 AMPICILLIN TRIHYDRATE (3)

12 ARIPIPRAZOLE TABLETS (1)

13 BIS (2-HYDROXY-5-CHLORO PHENYL) SULFIDE (1)

14 CALCIUM AMPHOMYCIN OINTMENT (1)

15 CARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ (1)

16 CEFACLOR (1)

17 CEFADROXIL MONOHYDRATE BULK (1)

18 CEFAZOLIN SODIUM (2)

19 CEPHALEXIN (2)

20 CEPHAPIRIN SODIUM STERILE (1)

21 CEPHRADINE (3)

22 CLOXACILLIN SODIUM (2)

23 COMPOUND SQ 21, 286 (1)

24 CRUDE AMPHOTERICIN SLURRY (1)

25 D-GLUCOSAMINE HYDROCHLORIDE SOLUTION, 2N SODIUM HYDROXIDE SOLUTION (1)

26 DESFLUORO TRIAMCINOLONE ACETONIDE (1)

27 DESONIDE (1)

28 DICLOXACILLIN SODIUM (3)

29 DIMETRIDAZOLE [EMTRYL] (1)

30 DROCINONIDE PHOSPHATE POTASSIUM (1)

31 FACILITIES AND CONTROLS PERSONNEL FOR MANUFACTURE AND CONTROL (1)

32 FACILITIES FOR THE G. OF SEMISOLIDS IN HUMACAO, PUERTO RICO (1)

33 FACILITIES LOCATED IN BARCELONETA, PUERTO RICO - PREVIOUSLY AN ANTIBIOTIC FILE (1)

34 FACILITIES LOCATED IN MAYAGUEZ, PUERTO RICO (1)

35 FLUPHENAZINE DECANOATE AND FLUPHENAZINE ENANTHATE (1)

36 FLUPHENAZINE DECANOATE INJ. (1)

37 FLUPHENAZINE HYDROCHLORIDE (1)

38 FORMULAS: RHODIAL & BOUQUET 5886 (1)

39 FR901228 (1)

40 FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION (1)

41 G. ANALYTICAL SPECS. & METHODS OF ANALYSIS FOR MEL B (ARSOBAL) (1)

42 GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE (1)

43 HALCINONIDE BULK (1)

44 HETACILLIN (1)

45 HETACILLIN ACID (1)

46 HETACILLIN POTASSIUM (3)

47 HUMAN MONOCLONAL ANTIBODY (MDX-060) TO CD30 (1)

48 HUMAN MONOCLONAL ANTIBODY (MDX-067) TO HEPARANASE (1)

49 HUMAN MONOCLONAL ANTIBODY (MDX-070) TO PROSTATE SPECIFIC MEMBRANE ANTIGEN (1)

50 HUMAN MONOCLONAL ANTIBODY (MDX-214) TO THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) (1)

51 HYDREA (1)

52 HYDROCHLORIDE 6484 R.P. (VET MED) (1)

53 HYDROXYUREA (1)

54 HYDROXYUREA LYOPHILIZED POWDER (1)

55 INSULIN (1)

56 IRBESARTAN (2)

57 JM-9 FOR INJECTION (1)

58 KANAMYCIN SULFATE (1)

59 KENALOG LOTION (1)

60 LISTING OF INDS (1)

61 MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER) (1)

62 MANUFACTURE OF HYDROXYUREA (1)

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

64 MARIZOMIB, A LYOPHILIZED POWDER FOR INJECTION WITH ACCOMPANYING DILUENT (1)

65 MDX-010 (ANTI-CTLA4 HUMAN MONOCLONAL ANTIBODY) (1)

66 MDX-015 (ANTI-IL15 HUMAN MONOCLONAL ANTIBODY) (1)

67 MDX-1100 (ANTI-CXCL 10/ANTI-IP-10 HUMAN MONOCLONAL ANTIBODY) (1)

68 MDX-1303 VALORTIM (TM), ANTI-BACILLUS ANTHRACIS PROTECTIVE ANTIGEN HUMAN MONOCLONAL ANTIBODY (1)

69 METHICILLIN SODIUM (1)

70 METHODS, FACILITIES, AND CONTROLS IN MAYAGUEZ, PUERTO RICO (1)

71 MURINE MONOCLONAL ANTIBODY (ALPHA CTLA4) TOCTLA4 (1)

72 MURINE MONOCLONAL ANTIBODY (PM-81) TO HUMAN MYELOID DIFFERENTIATION ANTIGEN (1)

73 MYCOSTATIN (NYSTATIN) (1)

74 MYCOSTATIN -20 IN PIGS (VET) (1)

75 NYDRAZID (1)

76 NYSTATIN (2)

77 OXACILLIN SODIUM (2)

78 OXACILLIN SODIUM FOR ORAL SOLUTION (1)

79 PATIENT STARTER PACKAGES (1)

80 PENICILLIN G POTASSIUM (1)

81 PENICILLIN G SODIUM (1)

82 PENICILLIN V POTASSIUM (2)

83 PENTAMIDINE ISETHIONATE (1)

84 PERSONNEL FOR PUERTO RICO PLANTS (1)

85 PICCOLITE RESIN S 115 L (1)

86 PIPERACILLIN MONOHYDRATE (1)

87 PIPERAZINE DIHYDROCHLORIDE AMMONIUM) RHODEX (VET MED) (1)

88 PLASTIC CONTAINERS (1)

89 POT. MELARSONYL-mel W (TRIMELARSAN)-G, SPECS, & METH. OF ANALYSIS (1)

90 PROLIXIN ELIXIR (FLUPHENAZINE HYDROCHLORIDE) (1)

91 RICIN CONJUGATED MURINE MONOCLONAL ANTIBODY (MDX-RA) TO HUMAN LENS EPITHELIAL CELLS (1)

92 STILBETIN SUPPLEMENT 50 (DIETHYLSTILBESTROL IN POLYETHYLENE GLYCOL) (1)

93 SUMMARIES OF THE BACKGROUND & QUALIFICATION OF INVEST & MONITORS (1)

94 TESTING FACILITIES FOR RAW MATERIALS & FINISHED GOODS (1)

95 TESTOLACTONE TABLETS, 250 MG (1)

96 TETRACYCLINE HYDROCHLORIDE (1)

97 TIPREDANE (1)

98 TRI-BUFFERED BUFFERIN (1)

99 TRIAMCINOLONE ACETONIDE CONCENTRATE (1)

100 TRIAMCINOLONE AND TRIAMCINOLONE ACETONIDE (1)

101 TRIAMCINOLONE DIACETATE, STERILE (1)

102 TRIAMCINOLONE HEXACETONIDE (1)

103 TRIFLUPROMAZINE AND TRIFLUPROMAZINE HCL (1)

104 VITAMINE B-12 (1)

105 WARFARIN SODIUM USP (1)

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01 APOTHECON INC DIV BRISTOL MYERS SQUIBB (1)

02 BARCELONETA INC DIV BRISTOL MYERS (7)

03 BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO (4)

04 BRISTOL MYERS (1)

05 BRISTOL MYERS CO INTERNATIONAL DIV (2)

06 BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS CO (1)

07 BRISTOL MYERS SQUIBB CO (41)

08 BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE (1)

09 BRISTOL MYERS SQUIBB INDUSTRIAL DIV (1)

10 BRISTOL MYERS SQUIBB LABORATORIES CO (1)

11 BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE (1)

12 CELGENE CORP (2)

13 ER SQUIBB AND SONS INC (32)

14 MEDAREX (1)

15 MEDAREX INC (7)

16 NORDA ESSENTIAL OIL AND CHEMICAL CO INC (1)

17 RHODIA INC (7)

18 SQUIBB (5)

19 SQUIBB DIAGNOSTICS (1)

20 SQUIBB G (2)

21 SQUIBB MARK DIV ER SQUIBB AND SONS INC (1)

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01 U.S.A (120)

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01 Active (1)

02 Inactive (119)

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01 Blank (120)

URL Supplier Web Content
BRISTOL MYERS SQUIBB ...
Inactive
10139
N/A
1968-06-10
II
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BRISTOL MYERS SQUIBB ...
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10155
N/A
1974-08-27
II
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BRISTOL MYERS SQUIBB ...
Inactive
10132
N/A
1989-06-20
II
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BRISTOL MYERS SQUIBB ...
Inactive
13527
N/A
1998-09-01
II
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BRISTOL MYERS SQUIBB ...
Inactive
13722
N/A
1998-09-01
II
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BARCELONETA INC DIV B...
Inactive
13525
N/A
1998-09-01
II
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BRISTOL MYERS SQUIBB ...
Inactive
13701
N/A
1998-09-01
II
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BRISTOL MYERS SQUIBB ...
Inactive
14274
N/A
1999-07-08
II
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BRISTOL MYERS
Inactive
13779
N/A
1998-09-01
II
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ER SQUIBB AND SONS IN...
Inactive
13532
N/A
1998-09-01
II
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