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

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01 17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE (1)

02 17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE (1)

03 5-AMINOSALICYLIC ACID (1)

04 6-METHYLPREDNISOLNE (1)

05 6-METHYLPREDNISOLONE-21-HEMISUCCINATE (1)

06 6a-METHYLPREDNISOLONE-21-ACETATE (1)

07 ACARBOSE (1)

08 ACEMETACIN (1)

09 ACETYLSALICYLIC ACID (ASPIRIN) (1)

10 ALCLOMETASONE DIPROPIONATE, USP (1)

11 AMIDOTRIZOIC ACID (UROGRAFIN ACID) (1)

12 AMPICILLIN (1)

13 AMPICILLIN SODIUM STERILE (1)

14 AMPICILLIN TRIHYDRATE (1)

15 ASOPRISNIL (1)

16 ASPIRIN USP (1)

17 ATAMESTANE (1)

18 AZELAIC ACID (1)

19 AZELAIC ACID (A) (1)

20 BAY 1903149 (THORIUM-227 CHLORIDE) (1)

21 BAY Y 3118 DRUG SUBSTANCE (1)

22 BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG. (1)

23 BETAMETHASONE (1)

24 BETAMETHASONE USP (1)

25 BETAMETHASONE VALERATE (1)

26 BOLDENONE UNDECYLENATE (1)

27 BOVINE THROMBIN (1)

28 CIPROFLOXACIN (1)

29 CIPROFLOXACIN HYDRATED DRUG SUBSTANCE (1)

30 CIPROFLOXACIN HYDROCHLORIDE (1)

31 CIPROFLOXACIN OD (1)

32 CLOCORTOLINE TRIMETHYL ACETATE (1)

33 CLOTRIMAZOLE (1)

34 CYPROTERONE ACETATE (1)

35 CYPROTERONE ACETATE AS PRODUCED IN THE BERLIN-WEDDING PLANT (1)

36 DANAZOL (2)

37 DEFLAZACORT (1)

38 DIENOGEST (1)

39 DIFLUCORTOLONE-21-VALERATE (1)

40 DROSPIRENONE (1)

41 DROXONE (1)

42 EDRUL TABS (20,30 & 240MG) (1)

43 ELTANOLONE (1)

44 EOB-DTPA (2)

45 ESTRADIOL (1)

46 ESTRADIOL ENANTHATE (1)

47 ESTRADIOL VALERATE (1)

48 ESTRADIOL-3-BENZOATE (1)

49 ESTRIOL (1)

50 ESTRONE (1)

51 ETHINAMATE (1)

52 ETHINYLESTRADIOL (1)

53 ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATE (1)

54 ETOFENAMATE (1)

55 FACIL, PERSONNEL & GEN OPERATING PROCEDS FOR MANATI, PR PLANT (1)

56 FACILITIES AND PERSONNEL AT WUPPERTAL, WEST GERMANY (1)

57 FACILITIES AND PERSONNEL IN LEVERKUSEN, GERMANY (1)

58 FACILITIES FOR THE G OF LIQUID & SOFT GELATIN CAPSULE PRODUCTS (1)

59 FACILITY AND OPERATING PROCEDURES IN DORMAGEN, WEST GERMANY (1)

60 FACILITY IN DARDILLY, FRANCE (1)

61 FLUDARA FILM-COATED TABLETS (1)

62 FLUDARABINE PHOSPHATE (1)

63 FLUOCORTIN BUTYLESTER (RECOMMENDED GENERIC NAME IS FLUOCORTIN BUTYL) (1)

64 G. AND CONTROL OF CLINICAL SUPPLIES IN BERLIN, W. GERMANY (1)

65 GADOBUTROL (1)

66 GADOPENTETIC ACID,MEGLUMINE SALT (1)

67 GEN. OPERATING PROCEDS FOR BULK PRODUCTS-SCHERING AG BERGKAMEN PLANT (1)

68 GENERAL OPERATING PROCEDURE (1)

69 GENERAL OPERATING PROCEDURES (1)

70 GENERAL OPERATING PROCEDURES FOR BULK PRODUCTS (1)

71 GENTAMICIN SULFATE (1)

72 GESTODENE (1)

73 HYALURONIC ACID BULK DRUG (1)

74 HYALURONIC ACID DRUG SUBSTANCE (EXHALE) (ETX100) (1)

75 HYDROCORTISONE (1)

76 HYDROCORTISONE ACETATE (1)

77 HYDROCORTISONE HEMISUCCINATE (1)

78 HYDROCORTISONE-17 VALERATE (1)

79 HYDROXY ACID (1)

80 HYDROXYPROGESTERONE CAPROATE (1)

81 ILOPROST (2)

82 ILOPROST B-CYCLODEXRIN CLATHRATE (1)

83 IOPROMIDE (1)

84 IOTROL USING 5-NITROISOPHTHALIC ACID AS STARTING MATERIAL (1)

85 IPODATE SODIUM (1)

86 ISONIAZID (NEOTEBEN) (1)

87 L-5-HYDROXYTRYPTOPHAN (1)

88 LEVONORGESTREL (1)

89 LEVONORGESTREL (DCM) (1)

90 LISURIDE HYDROGEN MALEATE (1)

91 LISURIDE HYDROGEN MELEATE (1)

92 MANUFACTURING SITE, FACILITIES, PERSONNEL AND PROCEDURES IN WEIMAR, GERMANY (1)

93 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GARBAGNATE MILANESE ITALY. (1)

94 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN POINTE CLAIRE, QUEBEC. (1)

95 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (2)

96 MEDROXYPROGESTERONE ACETATE (1)

97 MEGESTROL ACETATE (1)

98 MEGLUMINE (D(-) N- METHYLGLUIAMINE) (1)

99 MESTEROLONE (SH723) (1)

100 MESTRANOL (1)

101 METHYLTESTOSTERONE (1)

102 METRIFONATE DRUG PRODUCT (1)

103 METRIFONATE DRUG SUBSTANCE (1)

104 MICRONIZED PREDNISONE (1)

105 MICRONIZING LORMETAZEPAM (1)

106 MOLIDUSTAT SODIUM (MICRONIZED) DRUG SUBSTANCE (1)

107 MS-275 (1)

108 MS-275 FILM-COATED TABLETS (1)

109 MUZOLIMINE SEMIHYDRATE (1)

110 MYCOSPOR (BIFONAZOLE) CREAM 1% (1)

111 MYCOSPOR (BIFONAZOLE) SOLUTION 1% (1)

112 NANDROLONE DECANOATE (1)

113 NANDROLONE PHENPROPIONATE (1)

114 NANDROLONE PHENPROPIONATE,17 B-(3-PHENYLPROPIONYLOXY-)4-ESTREN-3-ONE (1)

115 NICLOSAMIDE 500MG TABLET (1)

116 NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE (1)

117 NIFEDIPINE (1)

118 NIFEDIPINE DRUG SUBSTANCE (1)

119 NIMODIPINE (1)

120 NIMODIPINE CAPS 10MG (bay e 9736) (1)

121 NISOLDIPINE (1)

122 NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS) (1)

123 NOCLOPROST BETA-CYCLODEXTRIN CLATHRATE (1)

124 NORETHINDRONE (1)

125 NORETHINDRONE ACETATE (1)

126 NORETHISTERONE (1)

127 NORETHISTERONE ENANTHATE (1)

128 NORGESTREL (1)

129 NORPLANT (LEVONORGESTREL IMPLANTS) (1)

130 ONAPRISTONE (1)

131 PANCURONIUM BROMIDE (1)

132 PARACETAMOL (1)

133 PIRAZOLAC (1)

134 PREDNISOLONE (1)

135 PREDNISOLONE 21-DISODIUM PHOSPHATE (1)

136 PREDNISOLONE 21-HEMISUCCINATE (1)

137 PREDNISOLONE-21-ACETATE (1)

138 PYNASUNATE (1)

139 QUINESTROL (1)

140 QUINIDINE GLUCONATE (1)

141 RECOMBINANT ADENO-ASSOCIATED VIRUS (RAAV) (1)

142 RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE (1)

143 RIVAROXABAN COATED TABLETS, 10 MG (1)

144 ROLIPRAM AS PRODUCED IN THE BERLIN PLANT (1)

145 SALAZOSULFAPYRIDINE (1)

146 SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT (1)

147 SH-714 (1)

148 SPIRONOLACTONE (1)

149 STERILE WATER FOR INJECTION (1)

150 SUCCINYL SULFATHIAZOLE (1)

151 TESTOSTERONE (2)

152 TESTOSTERONE ENANTHATE (1)

153 TESTOSTERONE PROPIONATE (1)

154 TESTOSTERONE UNDECANOATE (1)

155 TESTOSTERONE UNDECANOATE 750 MG I.M. (1)

156 THE COMPLETE BUTYL PRODUCT LINE (1)

157 TRASYLOL (APROTININ) DRUG PRODUCT (1)

158 TRASYLOL (APROTININ)-DRUG SUBSTANCE (1)

159 ULTRALANUM CREAM PLAIN (1)

160 ZK 112 119(6-BOCIP) (1)

161 ZK807834 (1)

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01 ASKLEPIOS BIOPHARMACEUTICAL INC (1)

02 BAYER AG (52)

03 BAYER CORP (12)

04 BAYER CORP PHARMACEUTICAL DIV (1)

05 BAYER HEALTHCARE AG (2)

06 BAYER HEALTHCARE LLC ANIMAL HEALTH DIV (1)

07 BAYER HEALTHCARE PHARMACEUTICALS INC (1)

08 BAYER OY (1)

09 BAYER PHARMA AG (4)

10 BAYER SCHERING PHARMA AG (6)

11 BAYER SPA (1)

12 MONSANTO CO (1)

13 PROQUINA SA (4)

14 SCHERING AG (68)

15 SCHERING AKTIENGESELLSCHAFT (1)

16 SCHERING CANADA INC (1)

17 SCHERING CHEMICALS LTD (1)

18 SCHERING GMBH UND CO PRODUKTIONS KG (1)

19 SCHERING PHARMACEUTICAL CORP (4)

20 SCHERING PLOUGH INC (1)

21 SCHERING PLOUGH INTERNATIONAL PHARMACEUTICAL DEVELOPMENT LABORATORY (1)

22 SCHERING PLOUGH PRODUCTS INC (1)

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01 Germany (161)

02 Mexico (4)

03 U.S.A (1)

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01 Active (35)

02 Inactive (131)

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01 Complete (7)

02 Blank (159)

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BAYER PHARMA AG
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5602
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1984-11-09
II
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SCHERING AG
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4587
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1982-06-14
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SCHERING AG
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4534
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1982-05-07
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SCHERING AG
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4516
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1982-05-04
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BAYER AG
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8539
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1990-04-23
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BAYER AG
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7865
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1989-01-09
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BAYER CORP
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4805
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1983-01-14
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SCHERING PHARMACEUTIC...
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8944
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1991-01-21
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SCHERING AG
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1015
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1966-12-02
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BAYER AG
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13688
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1998-09-01
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