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

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01 1-DOCOSANOL (1)

02 APIXABAN (1)

03 APREMILAST (1)

04 ARIPIPRAZOLE (1)

05 ATAZANAVIR SULFATE (1)

06 ATOMOXETINE HYDROCHLORIDE (1)

07 ATORVASTATIN CALCIUM (AMORPHOUS) (1)

08 ATORVASTATIN CALCIUM TRIHYDRATE (1)

09 BREXPIPRAZOLE (1)

10 CANAGLIFLOZIN (1)

11 CANDESARTAN CILEXETIL (1)

12 CARVEDILOL PHOSPHATE (1)

13 CELECOXIB (1)

14 CHLORTHALIDONE (1)

15 CINACALCET HYDROCHLORIDE (1)

16 CLOPIDOGREL BISULFATE USP (1)

17 CRISABOROLE (1)

18 CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED RELEASE PELLETS (1)

19 CYCLOSERINE (1)

20 DAPAGLIFLOZIN PREMIX (1)

21 DAPSONE (1)

22 DAPSONE USP (1)

23 DARIFENACIN HYDROBROMIDE (1)

24 DESVENLAFAXINE SUCCINATE (1)

25 DICLOFENAC SODIUM USP (1)

26 DIMETHYL FUMARATE (1)

27 DOLUTEGRAVIR SODIUM (1)

28 DONEPEZIL HCL (1)

29 DULOXETINE HYDROCHLORIDE (1)

30 DULOXETINE HYDROCHLORIDE DELAYED-RELEASE PELLETS (1)

31 EFAVIRENZ (1)

32 EFINACONAZOLE (1)

33 EMPAGLIFLOZIN (1)

34 EMTRICITABINE (1)

35 ENTACAPONE (1)

36 ESCITALOPRAM OXALATE (1)

37 ESOMEPRAZOLE MAGNESIUM DELAYED - RELEASE PELLETS (1)

38 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

39 ESZOPICLONE USP (1)

40 EZETIMIBE (1)

41 FAMCICLOVIR (1)

42 FEBUXOSTAT (1)

43 HYDRALAZINE HYDROCHLORIDE (1)

44 HYDROCHLOROTHIAZIDE USP (1)

45 IBANDRONATE SODIUM MONOHYDRATE (1)

46 INDOMETHACIN (1)

47 IRBESARTAN (1)

48 LABETALOL HYDROCHLORIDE USP (1)

49 LACOSAMIDE (1)

50 LANSOPRAZOLE (1)

51 LANSOPRAZOLE DELAYED - RELEASE PELLETS (1)

52 LEVOFLOXACIN HEMIHYDRATE (1)

53 LEVOTHYROXINE SODIUM USP (1)

54 LINAGLIPTIN (1)

55 LINEZOLID (1)

56 LOSARTAN POTASSIUM (1)

57 LURASIDONE HYDROCHLORIDE (1)

58 MEMANTINE HYDROCHLORIDE (1)

59 MEMANTINE HYDROCHLORIDE EXTENDED RELEASE PELLETS 28 MG (1)

60 METFORMIN HYDROCHLORIDE (1)

61 METHIMAZOLE (1)

62 METOPROLOL SUCCINATE (1)

63 MEXILETINE HYDROCHLORIDE (1)

64 MEXILETINE HYDROCHLORIDE USP (1)

65 MILNACIPRAN HYDROCHLORIDE (1)

66 MONTELUKAST SODIUM (1)

67 MOXIFLOXACIN HYDROCHLORIDE (1)

68 NEBIVOLOL HYDROCHLORIDE (1)

69 NITROFURANTOIN ANHYDROUS (MACROCRYSTAL) (1)

70 NITROFURANTOIN MONOHYDRATE (1)

71 OLANZAPINE USP (1)

72 OLMESARTAN MEDOXOMIL (1)

73 OSELTAMIVIR PHOSPHATE (1)

74 PALIPERIDONE USP (1)

75 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

76 PERPHENAZINE (1)

77 PIOGLITAZONE HYDROCHLORIDE (1)

78 PIRFENIDONE (1)

79 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

80 PRASUGREL HYDROCHLORIDE (1)

81 PREGABALIN USP (1)

82 PROPYLTHIOURACIL (1)

83 PYRAZINAMIDE (1)

84 QUETIAPINE FUMARATE (1)

85 RABEPRAZOLE SODIUM (1)

86 RASAGILINE MESYLATE (1)

87 REPAGLINIDE (1)

88 RIFAPENTINE (1)

89 RISEDRONATE SODIUM (1)

90 RIVAROXABAN (1)

91 RIVASTIGMINE TARTRATE (1)

92 RIZATRIPTAN BENZOATE (1)

93 ROSUVASTATIN CALCIUM (1)

94 SACUBITRIL/VALSARTAN (1)

95 SILDENAFIL CITRATE USP (1)

96 SILODOSIN (1)

97 SITAGLIPTIN PHOSPHATE (MONOHYDRATE) (1)

98 SODIUM ZIRCONIUM CYCLOSILICATE (1)

99 TADALAFIL (1)

100 TAMSULOSIN HYDROCHLORIDE MODIFIED RELEASE PELLETS 0.4 MG/ 275MG (1)

101 TAMSULOSIN HYDROCHLORIDE USP (1)

102 TELMISARTAN (1)

103 TENOFOVIR ALAFENAMIDE FUMARATE (2)

104 TENOFOVIR DISOPROXIL FUMARATE (1)

105 TICAGRELOR (1)

106 TOFACITINIB CITRATE (1)

107 TOLTERODINE TARTRATE USP (1)

108 TRAMADOL HYDROCHLORIDE USP (1)

109 TROSPIUM CHLORIDE (1)

110 VALACICLOVIR HYDROCHLORIDE DIHYDRATE (1)

111 VALSARTAN USP (1)

112 VARDENAFIL HYDROCHLORIDE TRIHYDRATE (1)

113 VARENICLINE TARTRATE (1)

114 VENLAFAXINE PROLONGED RELEASE PELLETS (37.5 MG/123 MG) (1)

115 VORTIOXETINE HYDROBROMIDE PREMIX (1)

116 ZIPRASIDONE HYDROCHLORIDE (1)

117 ZOLMITRIPTAN (1)

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01 MACLEODS PHARMACEUTICALS LTD (117)

02 SLOVAKOFARMA AS (1)

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01 India (118)

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01 Active (116)

02 Inactive (2)

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01 Complete (81)

02 Blank (37)

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