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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sandoz B2b to the U.S. FDA. Original Data : FDA Website

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01 3-DESACETYl-7-AMINOCEPHALOSPORANIC ACID (HACA) (1)

02 6-APA (6 AMINOPENICILLANIC ACID) (1)

03 6-METHYLERGOLENE-8-CARBOXYLIC ACID (1)

04 6-METHYLERGOLINE-8B-CARBOXYLIC ACID (1)

05 7-ACT (1)

06 7-AMCA (1)

07 7-AMINO-CEPHALOSPORANIC ACID (7-ACA) (1)

08 7-PACA (7-AMINO-3-PROPENYL-CEPHALOSPORANIC ACID) (1)

09 ACEPAM (1)

10 AMLODIPINE BESYLATE (1)

11 AMLODIPINE BESYLATE (PROCESS 2) (1)

12 AMOXCILLIN TRIHYDRATE USP (1)

13 AMOXICILLIN SODIUM (NON-STERILE BULK) (1)

14 AMOXICILLIN TRIHYDRATE (1)

15 AMPICILLIN ANHYDROUS (1)

16 AMPICILLIN SODIUM (STERILE) (1)

17 AMPICILLIN TRIHYDRATE (1)

18 APREMILAST (1)

19 ASCOMYCIN (1)

20 ATORVASTATIN ATV-44 INTERMEDIATE (1)

21 ATORVASTATIN CALCIUM (1)

22 AURANOFIN (1)

23 AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK) (1)

24 BOPINDOLOL (1)

25 BROMOCRIPTINE MESYLATE USP (1)

26 BUTALBITAL (2)

27 CALCIUM (GLUCOHYTONATE) GLUCEPTATE (1)

28 CANDESARTAN CILEXETIL (1)

29 CASPOFUNGIN ACETATE (1)

30 CEFAZOLIN SODIUM (STERILE) (1)

31 CEFDINIR (1)

32 CEFEPIME / L-ARGININE STERILE MIXTURE (1)

33 CEFIXIME (2)

34 CEFOTAXIME SODIUM STERILE (1)

35 CEFPODOXIME PROXETIL (2)

36 CEFPROZIL (1)

37 CEFTAZIDIME FOR INJECTION (1)

38 CEFTRIAXONE SODIUM (STERILE) (1)

39 CEFTRIAXONE SODIUM STERILE (1)

40 CEFUROXIME AXETIL (1)

41 CEFUROXIME N-BUTYL AMMONIUM (1)

42 CEPHALOSPORIN C SODIUM (1)

43 CHLORPHENIRAMINE BASE (1)

44 CHLORPHENIRAMINE MALEATE (1)

45 CHLORTHALIDONE (1)

46 CILASTATIN SODIUM STERILE (1)

47 CIMETIDINE HCL (1)

48 CLARITHROMYCIN (NON-STERILE BULK) (1)

49 CLAVULANATE POTASSIUM (2)

50 CLAVULANATE POTASSIUM DILUTED WITH MICROCRYSTALLINE CELLULOSE 1:1 (1)

51 CLAVULANATE POTASSIUM DILUTED WITH SILICON DIOXIDE 1:1 (1)

52 CLOFAZIMINE (1)

53 CLOXACILLIN SODIUM (NON-STERILE, BULK) (1)

54 CLOZAPINE (1)

55 CTAZ-TBE (CEFTAZIDIME-TERT-BUTYLESTER) (1)

56 CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE) (1)

57 CYCLOSPORIN D (1)

58 CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND. (1)

59 Cefepime, unsterile (1)

60 DIBENZOSUBERONE (1)

61 DICLOXACILLIN SODIUM (1)

62 DIHYDROERGOTAMINE MESYLATE (1)

63 DOLUTEGRAVIR SODIUM (1)

64 DORIPENEM MONOHYDRATE, STERILE (1)

65 ENALAPRIL MALEATE, ACTIVE SUBSTANCE (1)

66 ENTECAVIR MONOHYDRATE (1)

67 ERYTHROMYCIN (1)

68 ERYTHROMYCIN A (E)-9-OXIME (1)

69 ERYTHROMYCIN ETHYLSUCCINATE (1)

70 ESCITALOPRAM OXALATE (1)

71 ETOPOSIDE (VP 16-213) (ETHYLIDENE) (1)

72 FACILITIES AND PROCEDURES IN NUREMBERG, GERMANY (1)

73 FACILITIES AND PROCEDURES IN WHITBY, ONTARIO, CANADA. (1)

74 FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY CLINICAL TRIALS (1)

75 FERRIC CARBOXYMALTOSE (1)

76 FERUMOXYTOL (1)

77 FESOTERODINE FUMARATE (1)

78 FILGRASTIM (G-CSF) (1)

79 GABAPENTIN (NON-STERILE BULK) (1)

80 GENTAMICIN SULFATE (1)

81 GUANFACINE HCL (1)

82 GUANFACINE HYDROCHLORIDE (1)

83 HEPARIN SODIUM (1)

84 IMIPENEM AND CILASTATIN STERILE BLEND (1)

85 IMIPENEN STERILE (1)

86 INVESTIGATIONAL DRUGS (1)

87 L(-)-POLYLACTIC ACID FOR USE IN DRUG DOSAGE FORMS (1)

88 L-LEUCINE-ISOPROPYLAMINOCYCLOL HYDROCHLORIDE (1)

89 LANSOPROZOLE (1)

90 LEVOTHYROXINE SODIUM (1)

91 LIOTHYRONINE SODIUM (1)

92 LISINOPRIL ACTIVE DRUG SUBSTANCE (1)

93 LITHIUM CARBONATE (1)

94 LITHIUM CARBONATE ACTIVE SUBSTANCE (1)

95 LORAZEPAM (1)

96 LORAZETYL (1)

97 LOSARTAN POTASSIUM (1)

98 LOVASTATIN (1)

99 LOVASTATIN ACTIVE DRUG SUBSTANCE (1)

100 LOVASTATIN DRUG SUBSTANCE INTERMEDIATE (1)

101 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BASLE, SWITZERLAND. (1)

102 MEROPENEM TRIHYDRATE, STERILE (1)

103 MEROPENEM WITH SODIUM CARBONATE, STERILE BLEND (1)

104 MPI-ACA (1)

105 MYCOPHENOLATE MOFETIL (1)

106 MYCOPHENOLATE MOFETIL (PROCESS B), USP (1)

107 MYCOPHENOLIC ACID (1)

108 MYCOPHENOLIC ACID PURE (1)

109 MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATE (1)

110 NAFCILLIN ACID (1)

111 NAFTIFINE HCl (SN 105-843 ch) PRODUCED IN THE BASLE, SWITZERLAND PLANT (1)

112 NIFEDIPINE (1)

113 NITROFURANTOIN U.S.P (1)

114 OLANZAPINE (1)

115 OMEPRAZOLE (1)

116 OMEPRAZOLE ACTIVE DRUG SUBSTANCE (1)

117 OXACILLIN SODIUM (1)

118 OXAZEPAM (1)

119 OXYTETRACYCLINE HYDROCHLORIDE (1)

120 PACA, PURE (1)

121 PENICILLIN G BENZATHINE (STERILE) (1)

122 PENICILLIN G POTASSIUM STERILE AND PENICILLIN G POTASSIUM STERILE, BUFFERED (1)

123 PENICILLIN G SODIUM (STERILE) (1)

124 PENICILLIN G SODIUM BUFFERED (STERILE) (1)

125 PENICILLIN V POTASSIUM (1)

126 PHENIRAMINE MALEATE (1)

127 PHENYLALANINE-METHYLAMINOCYCLOL HCL (1)

128 PHYSOSTIGMINE SALICYLATE (1)

129 PIPERACILLIN (1)

130 PIPERACILLIN SODIUM & TAZOBACTAM SODIUM (8:1), STERILE (1)

131 POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1 (1)

132 POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 (1)

133 PRAVASTATIN SODIUM (2)

134 PRAVASTATIN T-BA, DRUG SUBSTANCE INTERMEDIATE (1)

135 PROPRANOLOL HCL (1)

136 PYCA.HI (PYRIDINIUM-7-AMINOCEPHALOSPORANIC ACID HYDROIODIDE) (1)

137 PYRILAMINE MALEATE USP (1)

138 RAPAMYCIN (2)

139 ROSIGLITAZONE MALEATE (1)

140 ROSUVASTATIN CALCIUM (1)

141 ROSUVASTATIN CALCIUM (PROCESS B) (1)

142 ROSUVASTATIN CALCIUM (PROCESS C) (1)

143 RS-86 AMPULS 10 mg/ml AS PRODUCED IN THE BASLE, SWITZERLAND PLANT (1)

144 RS-86 CAPSULES IN 0.25 mg AND 1.0 mg (BASLE, SWITZERLAND PLANT) (1)

145 RS-86 HYDROBROMIDE AS PRODUCED IN THE BASLE, SWITZERLAND PLANT (1)

146 SACA SODIUM SALT (1)

147 SDZ PSC 833 (1)

148 SF86-327 (E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YUL)-N--METHYL-1-NAPHTHALALENE (1)

149 SILVER SULFADIAZINE (1)

150 SIMVASTATIN (2)

151 SOMATROPIN (HUMAN GROWTH HORMONE) SANDOZ (1)

152 STERILE BULK MIXTURE AMPICILLIN/SULBACTAM FOR INJECTION (1)

153 STERILE NAFCILLIN SODIUM, BUFFERED (1)

154 STERILE OXACILLIN SODIUM, BUFFERED (1)

155 STERILE PENICILLIN G POTASSIUM BUFFERED (1)

156 STERILE PENICILLIN G PROCAINE (1)

157 SUGAMMADEX SODIUM (1)

158 SULBACTAM SODIUM (STERILE) (1)

159 SULFAMETHOXAZOLE (1)

160 TACROLIMUS (1)

161 TACROLIMUS (PROCESS II) (1)

162 TAMSULOSIN HYDROCHLORIDE (1)

163 TDM-85-530 b (1)

164 TEMAZEPAM (1)

165 TEMSIROLIMUS (1)

166 TENIPOSIDE (VM 26) (1)

167 THIAMYLAL SODIUM (1)

168 THIETHYLPERAZINE MALEATE (1)

169 TIAMULIN BASE (1)

170 TIAMULIN FUMARATE (1)

171 TICAGRELOR (1)

172 TIZANIDINE HYDROCHLORIDE (1)

173 TOLTERODINE TARTRATE (1)

174 VANCOMYCIN HYDROCHLORIDE (2)

175 VEPESID AMPULS, 100mg./5ml. (1)

176 VICA (PURE) (1)

177 VICA CRUDE (1)

178 VICA, PURE (3-VINYL-ACA) (1)

179 VORTIOXETINE HYDROBROMIDE (1)

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01 GEMA SA (1)

02 LEK PHARMACEUTICAL AND CHEMICAL CO DD (9)

03 LEK PHARMACEUTICALS DD (43)

04 NOVARTIS PHARMACEUTICAL CORP (1)

05 NOVARTIS PHARMACEUTICALS CORP (4)

06 SANDOZ AG (1)

07 SANDOZ CANADA INC (1)

08 SANDOZ GMBH (46)

09 SANDOZ HUNINGUE SA PRODUCTION PHARMA (1)

10 SANDOZ INDIA LTD (1)

11 SANDOZ INDUSTRIAL PRODUCTS GMBH (6)

12 SANDOZ INDUSTRIAL PRODUCTS SA (14)

13 SANDOZ INDUSTRIAL PRODUCTS SPA (5)

14 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT (28)

15 SANDOZ PHARM CORP (1)

16 SANDOZ PHARMA LTD (2)

17 SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC (7)

18 SANDOZ PRIVATE LTD (14)

19 SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE TICARET AS (2)

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01 Austria (40)

02 Germany (94)

03 Slovenia (52)

04 Switzerland (1)

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01 Active (70)

02 Inactive (117)

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01 Complete (23)

02 Blank (164)

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