FDA.reportPublic FDA data

Application 211659

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL10MGNoNo
002BACLOFENBACLOFENTABLET;ORAL20MGNoNo
003BACLOFENBACLOFENTABLET;ORAL5MGNoNo
004BACLOFENBACLOFENTABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4682BaclofenBaclofenA-S Medication SolutionsANDACurrent
50090-4682BaclofenBaclofenA-S Medication SolutionsANDACurrent
50090-6149BaclofenBaclofenA-S Medication SolutionsANDACurrent
50268-105BaclofenBaclofenAvPAKANDACurrent
50268-105BaclofenBaclofenAvPAKANDACurrent
50268-106BaclofenBaclofenAvPAKANDACurrent
50268-106BaclofenBaclofenAvPAKANDACurrent
50268-107BaclofenBaclofenAvPAKANDACurrent
50268-107BaclofenBaclofenAvPAKANDACurrent
68788-7551BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7551BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7562BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7562BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2470BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70710-1285BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1285BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1285BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1285BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1285BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1286BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1286BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1286BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1286BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1286BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1609BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1609BaclofenBaclofenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1448BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1448BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1448BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1448BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1449BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1449BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1449BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1449BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1586BaclofenBaclofenCadila Healthcare LimitedANDACurrent
70771-1586BaclofenBaclofenCadila Healthcare LimitedANDACurrent
71335-1356BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1356BaclofenBaclofenBryant Ranch PrepackANDACurrent