FDA.reportPublic FDA data

Application 078235

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7562TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7563TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7564TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7565TopiramateTopiramateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6928topiramatetopiramateMajor PharmaceuticalsANDACurrent
0904-6928topiramatetopiramateMajor PharmaceuticalsANDACurrent
0904-6929topiramatetopiramateMajor PharmaceuticalsANDACurrent
0904-6929topiramatetopiramateMajor PharmaceuticalsANDACurrent
45865-963topiramatetopiramatemedsource pharmaceuticalsANDACurrent
50090-3926topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-3926topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-3926topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-3926topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-5309topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-5309topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-5309topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-5853topiramatetopiramateA-S Medication SolutionsANDACurrent
50436-0139topiramatetopiramateUnit Dose ServicesANDACurrent
51655-429topiramatetopiramateNorthwind PharmaceuticalsANDACurrent
51655-429topiramatetopiramateNorthwind PharmaceuticalsANDACurrent
53808-0921topiramatetopiramateState of Florida DOH Central PharmacyANDACurrent
53808-1132topiramatetopiramateDOH CENTRAL PHARMACYANDACurrent
55154-7142topiramatetopiramateCardinal HealthANDACurrent
55154-7142topiramatetopiramateCardinal HealthANDACurrent
55154-7142topiramatetopiramateCardinal Health 107, LLCANDACurrent
55154-7142topiramatetopiramateCardinal HealthANDACurrent
55154-7142topiramatetopiramateCardinal HealthANDACurrent
55154-7146topiramatetopiramateCardinal HealthANDACurrent
55154-7146topiramatetopiramateCardinal HealthANDACurrent
55154-7146topiramatetopiramateCardinal Health 107, LLCANDACurrent
55154-7146topiramatetopiramateCardinal HealthANDACurrent
55154-7146topiramatetopiramateCardinal HealthANDACurrent
55700-210TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-075topiramatetopiramateSt. Mary's Medical Park PharmacyANDACurrent
60760-514topiramatetopiramateSt. Mary's Medical Park PharmacyANDACurrent
60760-577topiramatetopiramateSt. Mary's Medical Park PharmacyANDACurrent
60760-577topiramatetopiramateSt. Mary's Medical Park PharmacyANDACurrent
60760-577topiramatetopiramateST. MARY'S MEDICAL PARK PHARMACYANDACurrent
61919-883TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-883TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-883TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-883TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
63629-8189topiramatetopiramateBryant Ranch PrepackANDACurrent
65841-647topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-647topiramatetopiramateZydus Lifesciences LimitedANDACurrent
65841-647topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-647topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-648topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-648topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-648topiramatetopiramateZydus Lifesciences LimitedANDACurrent
65841-648topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-649topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-649topiramatetopiramateZydus Lifesciences LimitedANDACurrent
65841-649topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-649topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-650topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-650topiramatetopiramateZydus Lifesciences LimitedANDACurrent
65841-650topiramatetopiramateCadila Healthcare LimitedANDACurrent
65841-650topiramatetopiramateCadila Healthcare LimitedANDACurrent
68071-4756topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4756topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4793topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4793topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4877topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4877topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-342TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-342TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-342TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-342TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-342TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-343TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-343TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-343TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-344TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-344TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-344TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-344TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-344TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-345TopiramateTopiramateAmerican Health PackagingANDACurrent
68084-345TopiramateTopiramateAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44379ORIG2009-04-14