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01 16-APA

02 17-ADCA

03 17-AMINO CEPHALOSPORANIC ACID (7-ACA)

04 1AMIKACIN BASE

05 1AMIKACIN SULFATE

06 1AMOXICILLIN TRIHYDRATE

07 1AMPHOTERICIN B

08 1AMPHOTERICIN NON PARENTAL GRADE

09 1AMPICILLIN

10 1AMPICILLIN SODIUM

11 3AMPICILLIN TRIHYDRATE

12 1ARIPIPRAZOLE TABLETS

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

14 1CALCIUM AMPHOMYCIN OINTMENT

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

16 1CEFACLOR

17 1CEFADROXIL MONOHYDRATE BULK

18 2CEFAZOLIN SODIUM

19 2CEPHALEXIN

20 1CEPHAPIRIN SODIUM STERILE

21 3CEPHRADINE

22 2CLOXACILLIN SODIUM

23 1COMPOUND SQ 21, 286

24 1CRUDE AMPHOTERICIN SLURRY

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

26 1DESFLUORO TRIAMCINOLONE ACETONIDE

27 1DESONIDE

28 3DICLOXACILLIN SODIUM

29 1DIMETRIDAZOLE [EMTRYL]

30 1DROCINONIDE PHOSPHATE POTASSIUM

31 1FACILITIES AND CONTROLS PERSONNEL FOR MANUFACTURE AND CONTROL

32 1FACILITIES FOR THE MFG. OF SEMISOLIDS IN HUMACAO, PUERTO RICO

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

34 1FACILITIES LOCATED IN MAYAGUEZ, PUERTO RICO

35 1FLUPHENAZINE DECANOATE AND FLUPHENAZINE ENANTHATE

36 1FLUPHENAZINE DECANOATE INJ.

37 1FLUPHENAZINE HYDROCHLORIDE

38 1FORMULAS: RHODIAL & BOUQUET 5886

39 1FR901228

40 1FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION

41 1GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE

42 1HALCINONIDE BULK

43 1HETACILLIN

44 1HETACILLIN ACID

45 3HETACILLIN POTASSIUM

46 1HUMAN MONOCLONAL ANTIBODY (MDX-060) TO CD30

47 1HUMAN MONOCLONAL ANTIBODY (MDX-067) TO HEPARANASE

48 1HUMAN MONOCLONAL ANTIBODY (MDX-070) TO PROSTATE SPECIFIC MEMBRANE ANTIGEN

49 1HUMAN MONOCLONAL ANTIBODY (MDX-214) TO THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR)

50 1HYDREA

51 1HYDROCHLORIDE 6484 R.P. (VET MED)

52 1HYDROXYUREA

53 1HYDROXYUREA LYOPHILIZED POWDER

54 1INSULIN

55 2IRBESARTAN

56 1JM-9 FOR INJECTION

57 1KANAMYCIN SULFATE

58 1KENALOG LOTION

59 1LISTING OF INDS

60 1MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER)

61 1MANUFACTURE OF HYDROXYUREA

62 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.

63 1MARIZOMIB, A LYOPHILIZED POWDER FOR INJECTION WITH ACCOMPANYING DILUENT

64 1MDX-010 (ANTI-CTLA4 HUMAN MONOCLONAL ANTIBODY)

65 1MDX-015 (ANTI-IL15 HUMAN MONOCLONAL ANTIBODY)

66 1MDX-1100 (ANTI-CXCL 10/ANTI-IP-10 HUMAN MONOCLONAL ANTIBODY)

67 1MDX-1303 VALORTIM (TM), ANTI-BACILLUS ANTHRACIS PROTECTIVE ANTIGEN HUMAN MONOCLONAL ANTIBODY

68 1METHICILLIN SODIUM

69 1METHODS, FACILITIES, AND CONTROLS IN MAYAGUEZ, PUERTO RICO

70 1MFG. ANALYTICAL SPECS. & METHODS OF ANALYSIS FOR MEL B (ARSOBAL)

71 1MURINE MONOCLONAL ANTIBODY (ALPHA CTLA4) TOCTLA4

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

73 1MYCOSTATIN (NYSTATIN)

74 1MYCOSTATIN -20 IN PIGS (VET)

75 1NYDRAZID

76 2NYSTATIN

77 2OXACILLIN SODIUM

78 1OXACILLIN SODIUM FOR ORAL SOLUTION

79 1PATIENT STARTER PACKAGES

80 1PENICILLIN G POTASSIUM

81 1PENICILLIN G SODIUM

82 2PENICILLIN V POTASSIUM

83 1PENTAMIDINE ISETHIONATE

84 1PERSONNEL FOR PUERTO RICO PLANTS

85 1PICCOLITE RESIN S 115 L

86 1PIPERACILLIN MONOHYDRATE

87 1PIPERAZINE DIHYDROCHLORIDE AMMONIUM) RHODEX (VET MED)

88 1PLASTIC CONTAINERS

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

90 1PROLIXIN ELIXIR (FLUPHENAZINE HYDROCHLORIDE)

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

92 1STILBETIN SUPPLEMENT 50 (DIETHYLSTILBESTROL IN POLYETHYLENE GLYCOL)

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

94 1TESTING FACILITIES FOR RAW MATERIALS & FINISHED GOODS

95 1TESTOLACTONE TABLETS, 250 MG

96 1TETRACYCLINE HYDROCHLORIDE

97 1TIPREDANE

98 1TRI-BUFFERED BUFFERIN

99 1TRIAMCINOLONE ACETONIDE CONCENTRATE

100 1TRIAMCINOLONE AND TRIAMCINOLONE ACETONIDE

101 1TRIAMCINOLONE DIACETATE, STERILE

102 1TRIAMCINOLONE HEXACETONIDE

103 1TRIFLUPROMAZINE AND TRIFLUPROMAZINE HCL

104 1VITAMINE B-12

105 1WARFARIN SODIUM USP

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