FDA.report

Application 090278

Type
ANDA
Sponsor
SUN PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-083TopiramateTopiramateApotheca Inc.ANDACurrent
12634-452TopiramateTopiramateApotheca Inc.ANDACurrent
12634-453TopiramateTopiramateApotheca Inc.ANDACurrent
21695-162TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-205TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-348TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
21695-349TOPIRAMATETOPIRAMATERebel Distributors CorpANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-997TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-998TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-551TopiramateTopiramatemedsource pharmaceuticalsANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-707TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-710TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-711TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-712TopiramateTopiramateSun Pharmaceutical Industries, Inc.ANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3752TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3931TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3932TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3932TopiramateTopiramateA-S Medication SolutionsANDACurrent
50436-9952TopiramateTopiramateUnit Dose ServicesANDACurrent
52959-643TOPIRAMATETOPIRAMATEH.J. Harkins Company, Inc.ANDACurrent
53808-0967TOPIRAMATETOPIRAMATEState of Florida DOH Central PharmacyANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-596TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-691TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
55700-894TopiramateTopiramateQuality Care Products, LLCANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-439TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-817TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-817TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
239400ORIG12009-04-14FDA source fallback