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

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01 1-METHYL-1-(B-CHLOROETHYL) ETHYLENIMONIUM PICRYSULFONATE (1)

02 16-ALPHA-HYDROXYPREDNISOLONE (INTERMEDIATE) (1)

03 17B-ESTRADIOL-3-PHOSPHATE, ACID FORM (F00152) (1)

04 2-METHOXYESTRADIOL (1)

05 ALPHA-ESTRADIOL (1)

06 AMPROL SUPER PLUS (AMPROLIUM & ETHOPABATE) (VET) (1)

07 AMPROLIUM IN CHICKENS (VET) (1)

08 AMPROLIUM MEDICATED FEED -(3-NITRO-4-HYDROXYPHENYLARSONIC ACID) (VET) (1)

09 ANDROSTANOLONE (1)

10 ANDROSTERONE (1)

11 APRINOCID (1)

12 AQUEOUS SOLN RADIO-ACTIVE VITAMIN B12 (1)

13 BETAMETHASONE, USP (1)

14 BROMPHENIRAMINE MALEATE (1)

15 BULK FORM OF DRUG PRODUCT L-590,153 PROCESSED RAHWAY, N.J. FACILITIES (1)

16 BUTORPHANOL TARTRATE (1)

17 CHLORPHENIRAMINE MALEATE (1)

18 CONJUGATED ESTROGENS (1)

19 CORTATE (DESOXYCORTICOSTERONE ACETATE) (1)

20 DANAZOL (1)

21 DEHYDROISOANDROSTERONE (1)

22 DEHYDROISOANDROSTERONE POLYMORPH I (1)

23 DESOGESTREL TABLETS (75UG AND 150UG) (1)

24 DEXAMETHASONE (3)

25 DEXAMETHASONE 21-PHOSPHATE (1)

26 DEXAMETHASONE 21-TERTIARY BUTYLACETATE (1)

27 DEXAMETHASONE ACETATE (1)

28 DEXBROMPHENIRAMINE MALEATE (1)

29 DEXCHLORPHENIRAMINE MALEATE (1)

30 DIETHYLSTILBESTROL TRADE NAME: RUMESTROL "1" AND "2" (VET) (1)

31 DIFLUNISAL (1)

32 DILTIAZEM ER TABLETS (1)

33 DROPERIDOL (1)

34 EDROPHONIUM CHLORIDE (1)

35 ENALAPRIL MALEATE & DILTIAZEM ER TABLETS (1)

36 ESTERIFIED ESTROGENS TYPE BA (1)

37 ESTERIFIED ESTROGENS U.S.P. (1)

38 ESTRADIOL (1)

39 ESTRADIOL BENZOATE (1)

40 ESTRIOL (1)

41 ETHINYL ESTRADIOL (1)

42 FACILITIES AND OPERATING PROCEDURES IN CLERMONT-FERRAND,FRANCE (1)

43 FACILITY AND PROCEDURES IN OSS, THE NETHERLANDS - MOLENSTRAAT 110 (1)

44 FACILS., METHODS & CONTROLS FOR PROCESSING & PACKAGING OF DRUG PRODS. (1)

45 FENTANYL CITRATE (1)

46 FLUPHENAZINE DECANOATE (1)

47 HADACIDIN SOD. DIHYDRATE (NSC 521778) & HADACIDIN POTASS. NSC 72962 (1)

48 HEPARIN SODIUM III (1)

49 HUMAN MENOPAUSAL GONADOTROPHIN 100 (1)

50 HYALURONIC ACID LMW (1)

51 HYDROCORT. 21-PHOSPHATE & NEOMYCIN SO4--OPTHAL. SOL. 0.5% & INJECT (1)

52 IMIPRAMINE HCL (1)

53 J-107088 (1)

54 L-000825058 (1)

55 L-651,392-00N,4-BROMO-2,7-DIMETHOXY-3H-PHENOTHIAZIN-3-ONE (1)

56 LORATADINE (1)

57 MANUF&CONTROL FACILITIES&PROCEDURES AT SUBSIDIARY PLANT BARCELONETA,PR (1)

58 MANUF, CONTROL FACILITIES PROCEDURES FOR ALBANY, GA. PLANT (1)

59 MANUF. & CONTROL,FACILITIES & PROCEDURES-FOR ELKTON, VA. PLANT (1)

60 MANUF. CONTROL FACILITIES & PROCEDURES FOR DANVILLE PA PLANT (1)

61 MANUF.CONTROL,FACILITIES &PROCEDURES-AT RAHWAY, NJ PLANT (1)

62 MANUFACTURE AND CONTROL (1)

63 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HOBBESDON, HERFORDSHIRE, ENGLAND. (1)

64 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LE PUY CEDEX, FRANCE. (1)

65 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OKAZAKI CITY, JAPAN. (1)

66 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WILSON, NORTH CAROLINA. (1)

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

68 MEDROXYPROGESTERONE ACETATE MICRO (1)

69 MEGESTROL ACETATE (1)

70 MERCK (1)

71 MESTRANOL (2)

72 MK -2048A DRUG PRODUCT (1)

73 MK-2048 DRUG SUBSTANCE (1)

74 MK-4176 DRUG SUBSTANCE (1)

75 MK-6240 (1)

76 MK-803 (MEVINOLIN) AS SYNTHESIZED-PILOT PREPARATION OF RAHWAY NJ PLANT (1)

77 NALBUFINE HYDROCHLORIDE (1)

78 NALMEFENE HYDROCHLORIDE (1)

79 NALTREXONE (1)

80 NEOMYCIN SULFATE (1)

81 NITROGEN MUSTARDS (1)

82 NORANDROS TENEDIONE (NANDROLONE) (1)

83 NORETHISTERONE (1)

84 NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) (1)

85 NORGESTIMATE (1)

86 NORGESTOMET (1)

87 OMEPRAZOLE MAGNESIUM (1)

88 ORG 32489 RECOMBINANT FSH (1)

89 ORGABOLIN TABLETS 2 MG. (1)

90 OXANDROLONE (1)

91 PHENIRAMINE MALEATE (1)

92 PIMOZIDE (1)

93 PIPERAZINE ESTRONE SULPHATE (1)

94 PORCINE INSULIN HIGHLY PURIFIED (1)

95 PREDNISOLONE SODIUM PHOSPHATE (1)

96 PREPARATION OF CORTICOSTERONE FROM HYDROCORTISONE (1)

97 PREPARATION OF TEN STABLE ISOTOPE-LABELLED COMPOUNDS (1)

98 PRO-STREP CRUMBLES (VET) (1)

99 PRO-STREP IN SWINE (VET) (1)

100 PROCESS $ CONTROL DATE CONCERNING MANUFACTURE OF 2-ACETYLAMINA ETC. (1)

101 PROCHLORPERAZINE EDISYLATE (1)

102 PROGESTERONE (1)

103 PROMETHAZINE HCL (1)

104 PYRIDOSTIGMINE BROMIDE (1)

105 RATHDRUM, COUNTY WICKLOW, IRELAND (1)

106 STABILIZED MIXTURE OF CONJUGATED ESTROGENS (1)

107 STERILE DILUENT (1)

108 STERILE PROCESSING FACILITIES FOR PROGRAF(TACOLIMUS) AMPOULES AS LOCATED IN BANSAGH, KILLOGLIN, CO. KERRY, IRELAND. (1)

109 SYNTHETIC OXYTOCIN (1)

110 TECHNETIUM Tc 99M POLYPHOSPHATE KIT (1)

111 TESTOSTERONE PROPIONATE (1)

112 THIABENDAZOLE (1)

113 TIBOLONE (1)

114 TUBOCURARINE CHLORIDE (1)

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01 BANYU PHARMACEUTICAL CO LTD (2)

02 CHIBRET RESCTR DIV MERCK SHARP AND DOHME LABORATORIES (1)

03 LOFTUS BRYAN CHEMICALS LTD (4)

04 MERCK AND CO INC (13)

05 MERCK CHEMICAL MANUFACTURING DIV MERCK CO INC (1)

06 MERCK FROSST CANADA INC (1)

07 MERCK RESEARCH LABORATORIES DIV MERCK CO INC (2)

08 MERCK SHARP & DOHME DIV MERCK & CO INC (1)

09 MERCK SHARP & DOHME LTD (1)

10 MERCK SHARP & DOHME RESEARCH LABS (2)

11 MERCK SHARP AND DOHME CORP (4)

12 MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC (17)

13 MSD INTERNATIONAL GMBH (1)

14 MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) (1)

15 NV ORGANON (35)

16 ORGANICS LLC (1)

17 ORGANON INC (20)

18 ORGANON NV (1)

19 ORGANON OSS (1)

20 ORGANON SUB AKZONA INC (2)

21 SCHERING CORP (1)

22 SCHERING PLOUGH AVONDALE CO (5)

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01 Singapore (1)

02 U.S.A (116)

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01 Active (4)

02 Inactive (113)

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01 Blank (117)

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NV ORGANON
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2006-06-07
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ORGANICS LLC
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2004-06-10
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2007-09-06
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ORGANON INC
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1969-07-14
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NV ORGANON
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2003-10-15
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ORGANON SUB AKZONA IN...
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1971-07-28
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MERCK SHARP & DOHME D...
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MERCK AND CO INC
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1957-04-27
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MSD INTERNATIONAL GMB...
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1998-04-03
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LOFTUS BRYAN CHEMICAL...
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1983-03-31
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