FDA.reportPublic FDA data

Application 207382

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-769TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-769TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-769TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-769TopiramateTopiramateZydus Pharmaceuticals (USANDACurrent
68382-769TopiramateTopiramateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-863TopiramateTopiramateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-863TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-863TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-863TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-863TopiramateTopiramateZydus Pharmaceuticals (USANDACurrent
68382-864TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-864TopiramateTopiramateZydus Pharmaceuticals (USANDACurrent
68382-864TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-864TopiramateTopiramateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-864TopiramateTopiramateZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1315TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1315TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1315TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1315TopiramateTopiramateZydus Lifesciences LimitedANDACurrent
70771-1316TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1316TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1316TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1316TopiramateTopiramateZydus Lifesciences LimitedANDACurrent
70771-1317TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1317TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1317TopiramateTopiramateCadila Healthcare LimitedANDACurrent
70771-1317TopiramateTopiramateZydus Lifesciences LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50732ORIG2017-12-18