FDA.reportPublic FDA data

Application 076343

Type
ANDA
Sponsor
CIPLA LTD

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
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-729TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, InANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-734TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-735TopiramateTopiramatePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-459TopiramateTopiramateMedsource PharmaceuticalsANDACurrent
50090-3389TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3389TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3389TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3461TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-3461TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-4614TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-4614TopiramateTopiramateA-S Medication SolutionsANDACurrent
50090-4614TopiramateTopiramateA-S Medication SolutionsANDACurrent
50436-1220TopiramateTopiramateUnit Dose ServicesANDACurrent
51655-606TopiramateTopiramateNorthwind Pharmaceuticals, LLCANDACurrent
53217-291TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
53217-315TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
53217-329TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
55700-217TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-217TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-217TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-217TopiramateTopiramateLake Erie Medical DBA QuaANDACurrent
55700-217TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-226TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-226TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-226TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateQuality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-227TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-228TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-228TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-228TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-228TopiramateTopiramateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-228TopiramateTopiramateLake Erie Medical DBA QuaANDACurrent
60760-094TopiramateTopiramateSt. Mary's Medical Park PharmacyANDACurrent
61919-212TopiramateTopiramateDirect_RxANDACurrent
61919-318TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-369TOPIRAMATETOPIRAMATEDirectRXANDACurrent
61919-369TOPIRAMATETOPIRAMATEDirectRXANDACurrent
61919-679TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-679TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-679TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
61919-679TOPIRAMATETOPIRAMATEDirect_RxANDACurrent
63187-696TopiramateTopiramateProficient Rx LPANDACurrent
63187-696TopiramateTopiramateProficient Rx LPANDACurrent
63187-696TopiramateTopiramateProficient Rx LPANDACurrent
63187-696TopiramateTopiramateProficient Rx LPANDACurrent
63187-758TopiramateTopiramateProficient Rx LPANDACurrent
63187-758TopiramateTopiramateProficient Rx LPANDACurrent
63187-758TopiramateTopiramateProficient Rx LPANDACurrent
63187-773TopiramateTopiramateProficient Rx LPANDACurrent
63187-773TopiramateTopiramateProficient Rx LPANDACurrent
63187-773TopiramateTopiramateProficient Rx LPANDACurrent
63187-963TopiramateTopiramateProficient Rx LPANDACurrent
63187-963TopiramateTopiramateProficient Rx LPANDACurrent
68071-1971TopiramateTopiramateNuCare Pharmaceuticals, IANDACurrent
68071-1971TopiramateTopiramateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1971TopiramateTopiramateNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44308ORIG2009-04-14