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01 199M-TC-MURINE MONOCLONAL ANTIBODY (FAB') (T2G1S) TO HUMAN FIBRIN II (B-CHAIN)

02 1ALFENTANIL HYDROCHLORIDE

03 1ALTANSERIN TARTRATE (CODE NO. R 53200)

04 1ASTEMIZOLE-R 43512

05 1AZAPERONE

06 1BUPRENORPHINE BASE

07 1BUPRENORPHINE BASE DRUG SUBSTANCE

08 1BUTORPHANOL TARTRATE

09 1CARFENTANIL CITRATE (CODE NO. 33799)

10 1CARFENTANIL INJECTION 3MG./ML.

11 1CARISBAMAT (RWJ 333369)

12 1CARNIDAZOLE

13 1CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE

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

15 1CISAPRIDE(R051619) DRUG SUBSTANCE

16 1CLAZURIL - R 62690

17 1CLAZURIL TABLETS 2.5 MG (R 62690)

18 1DAPOXETINE HYDROCHLORIDE

19 1DARUNAVIR (R319064) DRUG SUBSTANCE

20 1DOMPERIDONE (RESEARCH CODE R-33812)

21 1DRAFLAZINE

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

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

24 1ETOMIDATE

25 1ETRAVIRINE (R165335) DRUG SUBSTANCE

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

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

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

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

30 1GALANTAMINE HYDROBROMIDE

31 1GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)

32 1HALOPERIDOL (R001625) DRUG SUBSTANCE

33 1HALOPERIDOL DECANOATE

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

35 1ITRACONAZOLE (R051211) DRUG SUBSTANCE

36 1KETOCONAZOLE DRUG SUBSTANCE

37 1LEVAMISOLE DRUG SUBSTANCE

38 1LEVAMISOLE HCL-R 12564

39 1LEVAMISOLE HYDROCHLORIDE CRUDE

40 1LEVOCABASTINE HCL.(BULK)

41 1LIAROZOLE FUMERATE DRUG SUBSTANCE

42 1LOPERAMIDE HYDROCHLORIDE

43 1LORCAINIDE HCL (JANSSEN CODE NO.R 15889

44 1LOVIRIDE DRUG SUBSTANCE

45 1LUBELUZOLE

46 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PHARMACEUTICAL PRODUCTION UNIT, BEERSE, BELGIUM.

47 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OLEN, BELGIUM.

48 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN STOUFFVILLE, ONTARIO, CANADA.

49 1MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT GEEL, BELGIUM.

50 1MEBENDAZOLE POLYMORH C

51 1MEBENDAZOLE POLYMORPH B DRUG SUBSTANCE

52 1METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)

53 1METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II)

54 1MICONAZOLE DRUG SUBSTANCE

55 1MICONAZOLE NITRATE DRUG SUBSTANCE

56 1NALMEFENE HYDROCHLORIDE

57 1NALOXONE HYDROCHLORIDE

58 1NALTREXONE BENZOATE

59 1NASAL NICOTINE SOLUTION (NNS)

60 1NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS

61 1NICORETTE

62 1NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT

63 1NICOTINE OROMUCOSAL SPRAY

64 1NICOTINE POLACRILEX LOZENGE

65 1NICOTINE PURIFICATION PROCESS

66 1NICOTINE RESIN COMPLEX 20%

67 1OXATOMIDE TABLETS 30 MG

68 1OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY

69 1PALIPERIDONE (R076477) DRUG SUBSTANCE

70 1PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE

71 1PIMOZIDE

72 1R093877

73 1R108512 DRUG SUBSTANCE

74 1RIDOGREL DRUG SUBSTANCE

75 1RILPIVIRINE DRUG SUBSTANCE

76 1RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTION

77 1RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE

78 1RISPERIDONE (R064766) DRUG SUBSTANCE

79 1RITANSERIN (CODE NO. R 55667 )

80 1RIVAROXABAN 10 MG FILM COATED TABLETS

81 1SIMEPREVIR (R494617) DRUG SUBSTANCE

82 1SUFENTANIL CITRATE

83 1TELAPREVIR DRUG SUBSTANCE (R600109)

84 1TERCONAZOLE (PRODUCT # R42470)

85 1TIPIFARNIB (R115777) DRUG SUBSTANCE

86 1TOPIRAMATE DRUG SUBSTANCE

87 1TRABECTEDIN (R279741)

88 1VOROZOLE DRUG SUBSTANCE

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