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

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01 7 AMINO CEPHALOSPORANIC ACID (1)

02 ABACAVIR SULFATE (1)

03 ABIRATERONE ACETATE (1)

04 ACAMPROSATE CALCIUM (2)

05 ACECLIDINE HYDROCHLORIDE (1)

06 ACITRETIN (1)

07 ACITRETIN (FORM I) (1)

08 ACYCLOVIR (2)

09 ACYCLOVIR SODIUM SALT (1)

10 ADAPALENE DRUG SUBSTANCE (1)

11 ALBUTEROL SULFATE (1)

12 ALITRETINOIN (1)

13 APREPITANT (1)

14 ARIPIPRAZOLE (1)

15 ASENAPINE MALEATE (1)

16 ATAZANAVIR SULFATE (1)

17 ATOMOXETINE HYDROCHLORIDE DRUG SUBSTANCE (1)

18 BALSALAZIDE DISODIUM SALT (1)

19 BENDAMUSTINE HCL (1)

20 BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL.) (1)

21 BENZPHETAMINE HYDROCHLORIDE (1)

22 BEZAFIBRATE (1)

23 BICALUTAMIDE DRUG SUBSTANCE (1)

24 BUMETANIDE (1)

25 BUPROPION HYDROCHLORIDE (3)

26 BUTOCONAZOLE NITRATE (1)

27 CANGRELOR TETRASODIUM (1)

28 CEFAZOLIN ACID (1)

29 CEFDINIR HYDRATE (1)

30 CEFUROXIME AXETIL (1)

31 CHOLINE FENOFIBRATE (1)

32 CICLETANINE HYDROCHLORIDE (1)

33 CLIDINIUM BROMIDE (1)

34 CLOFARABINE (1)

35 CLOFAZIMINE (1)

36 CLOFAZIMINE ORTHORHOMBIC (1)

37 CRISABOROLE (1)

38 CYCLOBENZAPRINE HYDROCHLORIDE (1)

39 DAPTOMYCIN (1)

40 DAUNORUBICIN HYDROCHLORIDE (1)

41 DEACETYL 7 AMINO CEPHALOSPORANIC ACID (HACA) (1)

42 DICYCLOMINE HYDROCHLORIDE (1)

43 DIENOGEST (1)

44 DIETHYLPROPION HCL (1)

45 DIHYDROERGOTAMINE MESYLATE (2)

46 DIOXANONE (1)

47 DOXORUBICIN HYDROCHLORIDE (1)

48 DULOXETINE HYDROCHLORIDE (1)

49 FACILITIES AND OEPRATING PROCEDURES IN MURCIA, SPAIN (1)

50 FAMCYCLOVIR (1)

51 FENFLURAMINE HYDROCHLORIDE (1)

52 FENOFIBRATE (2)

53 FENRETINIDE (1)

54 FLUOXETINE HCL EP/USP (1)

55 FLUOXETINE HYDROCHLORIDE (1)

56 FUROSEMIDE (2)

57 GEMCITABINE HYDROCHLORIDE (1)

58 GLIPIZIDE (1)

59 HYDROXYUREA (2)

60 IPRATROPIUM BROMIDE (1)

61 IRINOTECAN HYDROCHLORIDE TRIHYDRATE (1)

62 ISOTRETINOIN (1)

63 KETOCONAZOLE (1)

64 LANSOPRAZOLE (1)

65 LAROTRECTINIB SULFATE (1)

66 LENVATINIB MESYLATE (1)

67 LETROZOLE DRUG SUBSTANCE (1)

68 LIFITEGRAST (1)

69 LIFITEGRAST TYPE II (1)

70 LOPERAMIDE HYDROCHLORIDE (1)

71 Lenvatinib Mesylate form C (1)

72 MELOXICAM (1)

73 MELPHALAN HYDROCHLORIDE (1)

74 MEMANTINE HYDROCHLORIDE (1)

75 METFORMIN HYDROCHLORIDE (1)

76 MILNACIPRAN HYDROCHLORIDE (1)

77 MINOXIDIL (1)

78 MOXIFLOXACIN HYDROCHLORIDE (1)

79 MYCOPHENOLIC ACID (1)

80 MYCOPHENOLIC ACID NS TECHNICAL GRADE (1)

81 NICLOSAMIDE (1)

82 NINTEDANIB ESYLATE HEMIHYDRATE (1)

83 NIZATIDINE (1)

84 NYSTATIN (1)

85 OLAPARIB FORM A (1)

86 OMEGA-3-ACID ETHYL ESTERS (1)

87 ONCOFID-P20 (1)

88 OSPEMIFENE (1)

89 OTILONIUM BROMIDE (1)

90 OXANDROLONE (1)

91 OXAPROZIN (1)

92 PAROMOMYCIN SULFATE (1)

93 PENTAZOCINE HYDROCHLORIDE (1)

94 PERGOLIDE MESYLATE (1)

95 PHENDIMETRAZINE TARTRATE (1)

96 PHENTERMINE HYDROCHLORIDE (1)

97 POMALIDOMIDE (1)

98 POSACONAZOLE (1)

99 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (1)

100 QUETIAPINE FUMARATE (1)

101 RACEPINEPHRINE HYDROCHLORIDE (1)

102 RALOXIFENE HYDROCHLORIDE (1)

103 RIFABUTIN (1)

104 RIFAMPICIN (1)

105 RIFAMPIN (1)

106 RIFAMYCIN S (RODANO SITE) (1)

107 RIFAMYCIN S (SETTIMO SITE) (1)

108 RIFAMYCIN SV SODUM SALT (1)

109 RIFAXIMIN (1)

110 RITONAVIR (1)

111 ROTIGOTINE (1)

112 ROTIGOTINE POLYMORPH II (1)

113 SEVELAMER HYDROCHLORIDE (1)

114 SIBUTRAMINE HYDROCHLORIDE ANHYDROUS (1)

115 SILODOSIN (1)

116 SODIUM HYALURONATE OPHTHALMIC - FERMENTATIVE ORIGIN (TOPICAL GRADE) (1)

117 SPIRONOLACTONE (1)

118 TAMOXIFEN CITRATE (2)

119 TAZAROTENE (1)

120 TENIPOSIDE (1)

121 TERBINAFINE (1)

122 TERBINAFINE HYDROCHLORIDE (1)

123 TERBINAFINE HYDROCHLORIDE TYPE-2 (1)

124 TERCONAZOLE (1)

125 TERIFLUNOMIDE (1)

126 THALIDOMIDE (1)

127 THIOCTIC ACID (1)

128 TIGECYCLINE HYDROCHLORIDE (1)

129 TOFACITINIB CITRATE (1)

130 TOLVAPTAN (1)

131 TOREMIFENE CITRATE (2)

132 TRETINOIN (1)

133 TRETINOIN TYPE 2 (1)

134 TRIFAROTENE (1)

135 UMECLIDINIUM BROMIDE (1)

136 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE (1)

137 VALGANCICLOVIR HCL AMORPHOUS TYPE II (1)

138 VALGANCICLOVIR HCL CRYSTALLINE TYPE II (1)

139 VALGANCICLOVIR HYDROCHLORIDE AMORPHOUS (1)

140 VALGANCICLOVIR HYDROCHLORIDE CRYSTALLINE (1)

141 ZANUBRUTINIB (1)

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01 DERIVADOS QUIMICOS SA FINE CHEMICALS (3)

02 DERIVADOS QUIMICOS SAU (12)

03 FIDIA FARMACEUTICI SPA (1)

04 FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG (1)

05 OLON SPA (130)

06 OLON USA INC (2)

07 SOLMAG SPA (2)

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01 Italy (135)

02 Spain (16)

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01 Active (122)

02 Inactive (29)

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01 Complete (57)

02 Blank (94)

URL Supplier Web Content
OLON SPA
Active
9983
N/A
1975-03-20
II
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OLON USA INC
Active
20515
N/A
2007-05-08
II
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OLON SPA
Active
27376
Complete
2014-01-14
2013-09-06
2013-08-01
II
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OLON SPA
Active
21807
N/A
2008-07-14
II
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OLON SPA
Active
22625
Complete
2016-04-13
2015-09-18
2009-03-13
II
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OLON SPA
Active
35996
N/A
2022-11-17
II
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OLON SPA
Active
17001
Complete
2017-03-24
2017-03-14
2003-12-01
II
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OLON SPA
Active
24430
Complete
2016-06-10
2016-07-01
2010-11-11
II
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OLON SPA
Active
10685
Complete
2015-03-03
2014-04-22
1994-01-12
II
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OLON SPA
Active
20445
N/A
2007-04-05
II
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