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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by F. Hoffmann-la Roche to the U.S. FDA. Original Data : FDA Website

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01 1a,25-DIHYDROXYCHOLECALCIFEROL (RO21,5535) IN USAN IS CALCITRIOL (1)

02 4-EPITETRACYCLINE HYDROCHLORIDE (1)

03 5'-IODO-2'-DEOXYURIDINE (IDOXURIDINE, IDU) (1)

04 5-BROMO-2'-DEOXYURIDINE (1)

05 ACETAZOLAMIDE 500MG SRC (1)

06 ACTIFED S.A. CAPS--PSEUDOEPHEDRINE HCL 120MG/TRIPROLIDINE (1)

07 ACTIFED SUSTAINED RELEASE CAPSULES (1)

08 ADENOSINE DEAMINASE THERAPEUTIC GRADE (1)

09 ADENOSINE SUBLINGUAL TABLETS, 25 MG. (1)

10 ALPHA-METHYLDOPA, BULK FORM USP XIX (1)

11 AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS) (1)

12 AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS) (1)

13 AMITRIPTYLINE HYDROCHLORIDE (1)

14 ANTIPRESS TAB (1)

15 APTROPINE SULFATE CAPSULES (1)

16 B-AMINOPROPIONITRILE FUMARATE (1)

17 BETA-CAROTENE CAPS., 30MG AS PRODUCED IN NUTLEY,NJ FACILITIES (1)

18 BIOTIN (1)

19 BM 17.0744 NA (K-111) (1)

20 BROMPHENIRAMINE MALEATE/PHENYLPROPANOLAMINE C.R. TABLET (1)

21 BUTOCONAZOLE NITRATE (1)

22 BUTOCONAZOLE NITRATE 2% VAGINAL CREAM (1)

23 CAPTOPRIL TABLETS, 100MG. (1)

24 CARVEDILOL (1)

25 CATALASE THERAPEUTIC GRADE (1)

26 CCA (LOBENZARIT SODIUM) BULK DRUG (1)

27 CCA (LOBENZARIT SODIUM) TABLETS (1)

28 CED88004A (1)

29 CED88004S (1)

30 CEFTRIAXONE SODIUM (1)

31 CETIRIZINE HYDROCHLORIDE/PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, 10MG/240MG (1)

32 CHEMICAL PLANT HC-B 21 LOCATED IN MANNHEIM, GERMANY (1)

33 CHENODEOXYCHOLIC ACID TABLETS, 250MG (R08-2871) (1)

34 CHLORPHENIRAMINE MALEATE 12 MG SRC (1)

35 CLEARANCE FOR SALE OF PPOULTRY, TREATED WITH SULFADIMETHOXINE (VET) (1)

36 CLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG. (1)

37 COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307 (1)

38 CYTOSINE - ARABINOFURANOSIDE (1)

39 D,L-METIPRANOLOL (1)

40 D-PHENYLALANINE (1)

41 DECLINAX (DEBRISOQUIN SULFATE) TABS 10MG (1)

42 DESTAB(TM) FERROUS FUMARATE 90 S ULTRA (1)

43 DIDRONEL TABLETS, 200 MG, MNFG IN WESTPORT FACIL., ST.LOUIS, MISSOURI (1)

44 DIGOXIN PRODUCTS (1)

45 DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYLLINE) (1)

46 DIPHENHYDRAMINE HCL 100MG S.R. CAPSULES (1)

47 DISOPYRAMIDE S.R. CAPSULES (100 MG) (1)

48 DISOPYRAMIDE S.R. CAPSULES 150 MG. (1)

49 DORNASE ALFA INHALATION SOLUTION (GENENTECH) (1)

50 DOXEPIN (1)

51 DOXYLAMINE SUCCINATE (1)

52 ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 125MG (THEOPHYLLINE) (1)

53 ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 250MG. (THEOPHYLLINE) (1)

54 FACILITIES AND OPERATING PROCEDURES IN MANNHEIM, GERMANY (1)

55 FACILITIES AND OPERATING PROCEDURES IN SAO PAULO, BRAZIL (1)

56 FACILITIES CONTROL PERSONNEL (1)

57 FACILITIES UTILIZED IN DALRY, SCOTLAND (1)

58 FLUCYTOSINE CAPSULES AND MATCHING PLACEBO (1)

59 FLUOROLACTAM (1)

60 FLURBIPROFEN 200MG CAPS (1)

61 FRUCTOSE-1.6-BISPHOSPHATE (1)

62 GALACTOSE, THERAPEUTIC GRADE (1)

63 GUAIACOL-O-ETHYLBENZYLAMINE HCL (1)

64 GUAIACOL-O-ETHYLTOSYLATE (1)

65 HEXASTAT CAPS, 50 & 100MG (1)

66 HIVID DIDEOXYCYTIDINE SYRUP (1)

67 HUMAN GROWTH HORMONE RELEASING FACTOR-(1-44)-AMIDE (1)

68 HYBEPHEN -LA CAPSULES (1)

69 HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS (1)

70 IBANDRONATE, EDITION I (1)

71 IBUPROFEN DIHYDROCODEINE F.C. TABLETS (1)

72 INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ROCHE) (1)

73 KETOPROFEN S.R. CAPS., 150MG & 200MG (1)

74 L (1)

75 LEVODOPA INJECTABLE (1)

76 LEVODOPA S.R.C. 300MG (1)

77 LEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL. (1)

78 LIBRIUM; TRANIMAL (VET) (1)

79 MANUFACTURING FACILITIES AND CONTROLS (1)

80 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. (1)

81 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH SAN FRANCISCO. (1)

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

83 MEDIGESIC PLUS CAPS (1)

84 MEPROSPAN 200MG S.R. CAPS (1)

85 MEPROSPAN 400MG S.R. CAPS. (1)

86 METAXALONE (1)

87 METHYLDOPATE HYDROCHLORIDE (1)

88 METHYLTESTOSTERONE (1)

89 MICONAZOLE VAGINAL CREAM (1)

90 MSBA30K PEG REAGENT FOR MIRCERA (RO0503819) (1)

91 N-DECYLMETHYLSULFOXIDE (1)

92 NEOSTIGMINE METHYLSULFATE (1)

93 NICOTINIC ACID CAPSULES 125,250, & 500MG (1)

94 NITOMAN (TETRABENAZINE) TABLETS (1)

95 NITROFURANTOIN MACROCRYSTALLINE (1)

96 NOLAMINE REPEAT ACTION TABLETS (1)

97 NORPACE CR 100MG CAPSULES (1)

98 NORPACE (R) CR 150MG CAPSULES (1)

99 OCT (MAXACALCITOL) (1)

100 ORABASE HYDROCORTISONE ACETATE 0.5% ORAL PASTE (1)

101 ORTHO-NOVUM 1/5OE21 (1)

102 OXTRIPHYLLINE (CHOLINE THEOPHYLLINATE) (1)

103 PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG. (1)

104 PHENYLPROPANOLAMINE HCl/CHLORPHENIRAMINE MALEATE S.R.(B.F. ASCHER &CO) (1)

105 PHENYLPROPANOLAMINE75MG/CHLORPHENIRAMINE12MG SRCAP.:WHITEHALL LABS,INC (1)

106 POTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG (1)

107 PROCARBAZINE HYDROCHLORIDE PARENTERAL (1)

108 PRODUCTION PLANT HC-B 4 AND EXTRACTION PLANT HC-B 10 IN MANNHEIM, GERMANY (1)

109 PROPRANOLOL HYDROCHLORIDE (1)

110 PROPYLTHIOURACIL (1)

111 PROTAMINE HCL, RO 6-1588/1 (1)

112 PROTIRELIN (THYROTROPIN RELEASING HORMONE) (1)

113 PSEUDOEPHEDRINE HCL & CHLORPHENIRAMINE MALEATE S.R.C. (1)

114 PSEUDOEPHEDRINE HCL 120MG S.R. CAPS. (1)

115 PSEUDOEPHEDRINE HCL SRC (1)

116 PSEUDOEPHEDRINE HCl CONTROLLED BEADS (1)

117 PYRIDOSTIGMINE BROMIDE (1)

118 PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG (1)

119 PYRILAMINE - PHENYLEPHRINE SUSTAINED ACTION CAPSULES (1)

120 QUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973 (1)

121 QUININE SULFATE (1)

122 R03-0749/607 DISODIUM PYRIDOXAL PHOSPHATE INJ (1)

123 RIBOFLAVIN 5'-PHOSPHATE SODIUM (1)

124 RO 20 5933 (1)

125 RO 21-5816/000 24R,25-DIHYDROXYCHOLECALCIFEROL (1)

126 RO 3-1428 (5,8,LL,L4-EICOSATETRAYNOIC ACID) (1)

127 RO 5-9963 (DESMETHYLMISON IDAZOLE (1)

128 RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT) (1)

129 RU-VERT M TABLETS (MECLIZINE HCL) (1)

130 Ro 21-5535 (CALCITRIOL) AMPULS 2.5 mcg/0.5ml (1)

131 SEARLE ANTACID (1)

132 SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE NITRATE TABS (1)

133 SG-75 (NICORANDIL) BULK DRUG PRODUCT (1)

134 SPIRONOLACTONE (BULK FORM) USP XIX, BP 1973 (1)

135 SUCRALFATE (1)

136 SULFADOXINE (1)

137 TABLETTING AND ENCAPSULATING FACILITIES (1)

138 THEOBID & THEOBID JR. S.R. CAPS 130MG & 260MG (1)

139 THEOPHILLINE S.R. CAPSULES 250MG (1)

140 THEOPHYL S.R. CAPS 125MG & 250MG (THEOPHYLLINE)-FOR KNOLL PHARMA CO. (1)

141 THEOPHYLLINE S.R. CAPSULES 125MG (1)

142 THEOPHYLLINE S.R. CAPSULES, 250 MG. (1)

143 THEOPHYLLINE SR62.5MG MNFG IN ST.LOUIS,MO FOR SCHERING,KENILWORTH N.J. (1)

144 THEOPHYLLINE SUSTAINED RELEASE CAPSULES, 125 MG. (1)

145 THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTECH) (1)

146 TICLOPIDINE HCL- BOULDER, CO, SPRINGFIELD, MO, EVIONNAZ,SWITZ (1)

147 TOPICYCLINE (1)

148 TORASEMIDE (1)

149 TRETINOIN CAPSULES (1)

150 TROCINATE 100MG & 400MG (1)

151 TUMOR NECROSIS FACTOR RECEPTOR IMMUNOGLOBULIN G (1)

152 UNISOM CAPS(DOXYLAMINE USP) (1)

153 URSODEOXYCHOLIC ACID (RO13-1798) (1)

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01 BOEHRINGER KNOLL LTD (1)

02 BOEHRINGER MANNHEIM GMBH (16)

03 BOEHRINGER MANNHEIM SA (4)

04 CHUGAI PHARMACEUTICAL CO LTD (5)

05 FUJI CHEMICAL INDUSTRIES CO LTD (1)

06 GENENTECH INC (7)

07 HOFFMANN LA ROCHE INC (29)

08 HOFFMANN LAROCHE F AND CO LTD (1)

09 KV PHARMACEUTICAL CO (60)

10 ROCHE DIAGNOSTICS GMBH (19)

11 ROCHE PALO ALTO LLC (3)

12 ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INC (1)

13 ROCHE PRODUCTS INC (3)

14 ROCHE PRODUCTS LTD (1)

15 ROCHE QUIMICOS E FARMACEUTICOS SA (1)

16 ROCHE VITAMINS AND FINE CHEMICALS DIV HOFFMAN LAROCHE INC (1)

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01 Germany (40)

02 Japan (6)

03 Switzerland (100)

04 U.S.A (7)

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01 Active (2)

02 Inactive (151)

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01 Blank (153)

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HOFFMANN LA ROCHE INC
Inactive
2373
N/A
1974-12-13
II
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BOEHRINGER MANNHEIM S...
Inactive
11917
N/A
1996-04-09
II
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ROCHE DIAGNOSTICS GMB...
Inactive
3699
N/A
1980-01-18
II
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ROCHE DIAGNOSTICS GMB...
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12277
N/A
1996-12-16
II
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KV PHARMACEUTICAL CO
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2561
N/A
1975-08-30
II
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KV PHARMACEUTICAL CO
Inactive
2964
N/A
1977-06-07
II
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ROCHE DIAGNOSTICS GMB...
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8225
N/A
1989-09-21
II
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KV PHARMACEUTICAL CO
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8677
N/A
1990-07-26
II
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BOEHRINGER MANNHEIM G...
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3345
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1978-10-11
II
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BOEHRINGER MANNHEIM G...
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3966
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1980-09-26
II
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