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

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01 ALVIMOPAN DIHYDRATE (1)

02 AMBRISENTAN (1)

03 ANTILIRIUM (PHYSOSTIGMINE SALICYLATE) (1)

04 APIXABAN (1)

05 ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) (1)

06 ASPIRIN EC-2 (MICROENCAPSULATED) (1)

07 CAFFEINE MICROCAPS (1)

08 CAPTOPRIL-F 250MG C.R. TABLETS (1)

09 CAPTOPRIL-S 250MG C.R. TABLETS (1)

10 CEFUROXIME AXETIL AMORPHOUS (1)

11 CIMETIDINE BASE MICROCAPSULES (1)

12 CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) (1)

13 CYCLOSPORINE (1)

14 DEFERASIROX (1)

15 DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS (2)

16 DIFFUTAB SIMETRY BASE (1)

17 DIPHENHYDRAMINE CITRATE (MICROCAPS) (1)

18 DOCOSANOL (1)

19 DOXYCYCLINE (1)

20 DYREX INJECTABLE IN SWINE AND HORSES (VET) (1)

21 ENCAPSULATION (1)

22 ENZALUTAMIDE (1)

23 ERYTHROMYCIN 500MG. C.R.TABLETS (1)

24 EUR-1038 MODIFIED RELEASE CAPSULES (1)

25 EUR-1042 ORALLY DISINTEGRATING TABLETS (1)

26 EUR-1057 EXTENDED-RELEASE DOSAGE FORMS (1)

27 EUR-1084 ORALLY DISINTEGRATING TABLETS (1)

28 FACILITIES AND PERSONNEL IN RIO PIEDRAS, PUERTO RICO (1)

29 FACILITIES UTILIZED IN ST. LOUIS, MO (1)

30 FERRIC CITRATE (1)

31 FERRIC OXYHYDROXIDE (1)

32 FLURBIPROFEN 100 MG C.R.TABS (IN SYNCHRON VEHICLE (1)

33 FLURBIPROFEN 200 mg C.R. TABS (IN SYNCHRON VEHICLE (1)

34 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG650 MG (1)

35 HYDROCODONE BITARTRATE TABLETS, 10 MG (1)

36 IBUPROFEN 800 MG C.R. TABLETS (IN SYNCHRON VEHICLE) (1)

37 IMIQUIMOD (1)

38 IMIQUIMOD USP [NON-STERILE DRUG SUBSTANCE] (1)

39 INDOMETHACIN (1)

40 IRON DEXTRAN, 5% SOLUTION (1)

41 LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE (1)

42 MANUFACTURING SITE, FACILITIES , PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIBERTYVILLE, ILLINOIS. (1)

43 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERAING PROCEDURES IN CORONA, CALIFORNIA. (1)

44 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DAYTON, OHIO. (1)

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

46 MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DUBLIN, IRELAND. (1)

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

48 MEDICAINE 2%-MEPIVICAINE 2%, EPINEPHIDRINE 1/100000, 1.8 AMPOULES (1)

49 MEDICAINE 3%- MEPIVICAINE 3%, WITHOUT A VASOCONSTRICTOR, 1.8 AMPOULES (1)

50 MESTRANOL 3-METHOXY-172-ETHINYL-ESTRADIOL- MANUF PROCEDURES (1)

51 METOPROLOL SUCCINATE USP (1)

52 METOPROLOL TARTRATE USP (1)

53 MICROCAPS CIMETIDINE, USP (1)

54 MICROCAPS PHENYLPROPANOLAMINE HC1, USP (1)

55 MICROCAPS PSEUDOEPHEDRINE HCL (1)

56 MICROENCAPSULATED SULFAMETHOXAZOLE (1)

57 MICROENCAPSULATION PROCEDURE (1)

58 MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

59 NABUMETONE USP (1)

60 NICOTINE (1)

61 NICOTINE BITARTRATE DIHYDRATE (1)

62 NICOTINE POLACRILEX RESIN (1)

63 NITROFURANTOIN MACROCRYSTALS USP (1)

64 NITROFURANTOIN MONOHYDRATE USP (1)

65 NORTRIPTYLINE HYDROCHLORIDE USP (1)

66 OXYBUTYNIN BASE (1)

67 OXYBUTYNIN CHLORIDE USP (1)

68 PANCRELIPASE (ULTRASE) MINITABS (1)

69 PENTAERYTHRITOL TETRANITRATE (P.E.T.N.) 80mg. & 160mg C.R. TABLETS (1)

70 PERSONNEL,FACILITIES,CONTROLS (1)

71 POTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE (1)

72 PRAZOSIN HYDROCHLORIDE CONTROLLED RELEASE TABLETS (1)

73 PRILOCAINE USP (1)

74 PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG. (1)

75 PSEUDOEPHEDRINE HCL (MICROCAP) (1)

76 QUINIDINE GLUCONATE 650 MG. C.R. TABLETS (1)

77 RAMIPRIL USP (1)

78 RANITIDINE HYDROCHLORIDE FORM I BULK (2)

79 RANITIDINE HYDROCHLORIDE FORM II (1)

80 RENACIDEN IN DOGS AND CATS (VET) (1)

81 RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

82 ROPINIROLE HYDROCHLORIDE USP (1)

83 SODIUM FLUORIDE 22MG, SUSTAINED ACTION CAPSULES (1)

84 SODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS (1)

85 TAZAROTENE (1)

86 TELMISARTAN (1)

87 TENIACIDE IN DOGS, MICE AND CATS (VET) (1)

88 THIORIDAZINE HCL 200 MG C.R. TABS (IN SYNCHRON VEHICLE) (1)

89 THIORIDAZINE HCL 400MG S.R.TABS (IN SYNCHRON VEHICLE) (1)

90 THIORIDAZINE HCL. 50MG.C.R.TABLETS (1)

91 THIORIDAZINE HCL100MG CR(LD IN SYCHRON VEHICLE)MNFG INWOOD,NY (1)

92 THIORIDAZINE HCl C.R. TABLETS (IN SYNCHRON VEHICLE) (1)

93 TIZANIDINE HYDROCHLORIDE USP (1)

94 TM-1 (N-[2-(2-METHOXYPHENOXY)ETHYL]NORGLAUCINE) (1)

95 TOBRAMYCIN BASE USP (NON-STERILE BULK) (1)

96 TOBRAMYCIN SULPHATE USP (NON-STERILE BULK) (1)

97 TRANSDERMAL ESTRADIOL PATCH (1)

98 TRICHLORFON IN SWINE (INJECTABLE) (VET)--ADD. CORRES. TO D-637 (1)

99 TRIENTINE HYDROCHLORIDE USP (1)

100 VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)] (1)

101 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (1)

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01 ACTAVIS GROUP PTC EHF (5)

02 ALPHARMA APS (2)

03 AMERICAN HOME PRODUCTS (4)

04 EURAND AMERICA INC (16)

05 EURAND DIFFUCAP SA (1)

06 EURAND INC (3)

07 EURAND INTERNATIONAL SPA (2)

08 EURAND PHARMACEUTICALS INC (1)

09 EURAND SPA (1)

10 FAKO ILACLARI AS (4)

11 FOREST LABORATORIES INC (18)

12 FOREST LABORATORIES IRELAND LTD (1)

13 FOREST PHARMACEUTICALS INC (2)

14 LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT (1)

15 MEDIS (2)

16 NICOBRAND LTD (3)

17 TEVA PHARMACEUTICAL INDUSTRIES LTD (21)

18 WATSON LABORATORIES INC (10)

19 WATSON PHARMA PRIVATE LTD (5)

20 ZYDUS LIFESCIENCES LTD (1)

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01 China (1)

02 Iceland (2)

03 Ireland (47)

04 Turkey (4)

05 U.S.A (49)

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01 Active (26)

02 Inactive (77)

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01 Complete (10)

02 Blank (93)

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TEVA PHARMACEUTICAL I...
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2016-07-19
2016-05-18
2016-05-24
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WATSON PHARMA PRIVATE...
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2011-09-09
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FOREST PHARMACEUTICAL...
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3946
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1980-08-11
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WATSON PHARMA PRIVATE...
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2016-07-29
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ACTAVIS GROUP PTC EHF
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22983
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2009-07-24
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EURAND AMERICA INC
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8053
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1989-05-05
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EURAND AMERICA INC
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10643
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1993-12-30
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FOREST LABORATORIES I...
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1979-12-05
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FOREST LABORATORIES I...
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1979-12-05
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FAKO ILACLARI AS
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14653
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2000-01-03
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