FDA.reportPublic FDA data

Application 208963

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4425fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50090-4425fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50090-4426fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50090-4864fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50090-4864fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50090-5299fluconazolefluconazoleA-S Medication SolutionsANDACurrent
50436-1139fluconazolefluconazoleUnit Dose ServicesANDACurrent
60760-113fluconazolefluconazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-493FluconazoleFluconazoleDirect RxANDACurrent
61919-493FluconazoleFluconazoleDirect RxANDACurrent
63629-8054fluconazolefluconazoleBryant Ranch PrepackANDACurrent
68071-2601fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2609fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4386fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4386fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4437fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4501fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4501fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4501fluconazolefluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7150fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7150fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7150fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7150fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7150fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7203fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7203fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7888fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7888fluconazolefluconazolePreferred Pharmaceuticals Inc.ANDACurrent
70518-2411fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2411fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2411fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2411fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2411fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2415fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2415fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2415fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2415fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-2415fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70518-3100fluconazolefluconazoleREMEDYREPACK INC.ANDACurrent
70710-1137fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1137fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1137fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1137fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1138fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1138fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1138fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1138fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1139fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1139fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1139fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1139fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1140fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1140fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1140fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1140fluconazolefluconazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1063fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1063fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1063fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1063fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1064fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1064fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1064fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1064fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1065fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1065fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1065fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1065fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1066fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1066fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1066fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70771-1066fluconazolefluconazoleCadila Healthcare LimitedANDACurrent
70934-935fluconazolefluconazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-081fluconazolefluconazoleProficient Rx LPANDACurrent
71205-081fluconazolefluconazoleProficient Rx LPANDACurrent
71205-283fluconazolefluconazoleProficient Rx LPANDACurrent
71205-283fluconazolefluconazoleProficient Rx LPANDACurrent
71335-0686fluconazolefluconazoleBryant Ranch PrepackANDACurrent
71335-0686fluconazolefluconazoleBryant Ranch PrepackANDACurrent
71335-0686fluconazolefluconazoleBryant Ranch PrepackANDACurrent
71335-0686fluconazolefluconazoleBryant Ranch PrepackANDACurrent