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

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01 ABIRATERONE ACETATE USP (1)

02 ANASTROZOLE USP (1)

03 APIXABAN (2)

04 APREMILAST (1)

05 ARGATROBAN (1)

06 ATAZANAVIR SULFATE (1)

07 AZACITIDINE (1)

08 BENAZEPRIL HYDROCHLORIDE USP (1)

09 BIMATOPROST (1)

10 BIVALIRUDIN (1)

11 BORTEZOMIB (1)

12 BREXPIPRAZOLE (1)

13 CAPECITABINE (1)

14 CEDAZURIDINE (1)

15 CELECOXIB USP (1)

16 CLADRIBINE USP (1)

17 CLOFARABINE (1)

18 DANTROLENE SODIUM USP (1)

19 DECITABINE (2)

20 DESMOPRESSIN ACETATE (1)

21 DOCETAXEL TRIHYDRATE USP (1)

22 DOCETAXEL USP (2)

23 EFLORNITHINE HYDROCHLORIDE (1)

24 ELAGOLIX SODIUM (1)

25 ENTECAVIR MONOHYDRATE USP (1)

26 ENZALUTAMIDE (2)

27 EVEROLIMUS (1)

28 EXEMESTANE USP (1)

29 FLAVOXATE HYDROCHLORIDE (1)

30 FLUMAZENIL USP (1)

31 FLUTICASONE PROPIONATE (1)

32 FONDAPARINUX SODIUM USP (1)

33 FOSAPREPITANT DIMEGLUMINE (1)

34 FULVESTRANT USP (1)

35 GALANTAMINE (1)

36 GALANTAMINE HYDROBROMIDE USP (1)

37 GEFITINIB (1)

38 GEMCITABINE HYDROCHLORIDE USP (1)

39 GRANISETRON HYDROCHLORIDE (1)

40 IBRUTINIB (1)

41 IRINOTECAN HYDROCHLORIDE (1)

42 IVACAFTOR (1)

43 LAPATINIB DITOSYLATE (1)

44 LETROZOLE (1)

45 LEUPROLIDE MESYLATE (1)

46 LEVONORGESTREL USP (1)

47 LIFITEGRAST (1)

48 LIRAGLUTIDE (1)

49 MESTRANOL USP (1)

50 NELARABINE (1)

51 NORGESTREL USP (1)

52 OCTREOTIDE ACETATE (1)

53 OLAPARIB (1)

54 OMEPRAZOLE (1)

55 OMEPRAZOLE USP (1)

56 ONDANSETRON HYDROCHLORIDE USP (1)

57 OSIMERTINIB MESYLATE (1)

58 OXANDROLONE (1)

59 PACLITAXEL USP (2)

60 PALBOCICLIB (1)

61 PEMETREXED (1)

62 PEMETREXED DISODIUM HEMIPENTAHYDRATE (1)

63 PEMETREXED DISODIUM USP (1)

64 REGADENOSON (1)

65 RILUZOLE USP (1)

66 ROFLUMILAST (1)

67 SN38 (1)

68 SUGAMMADEX SODIUM (1)

69 TAMSULOSIN HYDROCHLORIDE USP (1)

70 TERIPARATIDE USP (1)

71 TOPIRAMATE USP (1)

72 TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE (1)

73 TRAVOPROST USP (1)

74 ZOLEDRONIC ACID (1)

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01 SCINOPHARM TAIWAN LTD (79)

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01 Taiwan (79)

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01 Active (67)

02 Inactive (12)

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01 Complete (37)

02 Blank (42)

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SCINOPHARM TAIWAN LTD
Active
30587
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2016-06-01
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SCINOPHARM TAIWAN LTD
Active
18335
Complete
2013-07-31
2013-07-18
2005-05-06
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SCINOPHARM TAIWAN LTD
Inactive
30440
N/A
2016-04-01
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SCINOPHARM TAIWAN LTD
Active
37669
N/A
2022-12-30
II
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SCINOPHARM TAIWAN LTD
Active
32058
N/A
2017-11-13
II
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SCINOPHARM TAIWAN LTD
Inactive
22935
N/A
2009-07-10
II
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SCINOPHARM TAIWAN LTD
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27562
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2018-02-12
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SCINOPHARM TAIWAN LTD
Active
22360
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2013-04-04
2012-11-29
2008-12-31
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SCINOPHARM TAIWAN LTD
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16072
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2002-07-22
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SCINOPHARM TAIWAN LTD
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27217
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2013-06-14
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