FDA.reportPublic FDA data

Application 079162

Type
ANDA
Sponsor
INVAGEN PHARMS

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
10544-628TopiramatetopiramateBlenheim Pharmacal, Inc.ANDACurrent
31722-278TopiramateTopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-279TopiramateTopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-280TopiramateTopiramateCamber Pharmaceuticals, Inc.ANDACurrent
31722-281TopiramateTopiramateCamber Pharmaceuticals, Inc.ANDACurrent
33261-400TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
33261-480TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
43353-695TopiramatetopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-696TopiramatetopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-697TopiramatetopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50436-9949TopiramateTopiramateUnit Dose ServicesANDACurrent
50436-9949TopiramateTopiramateUnit Dose ServicesANDACurrent
50436-9950TopiramateTopiramateUnit Dose ServicesANDACurrent
50436-9951TopiramateTopiramateUnit Dose ServicesANDACurrent
50436-9951TopiramateTopiramateUnit Dose ServicesANDACurrent
53217-274TopiramateTopiramateAidarex Pharmaceuticals LLCANDACurrent
60429-769TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-769TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-770TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-770TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-771TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-771TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-772TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
60429-772TopiramatetopiramateGolden State Medical Supply, Inc.ANDACurrent
61919-172TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-172TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-190TOPIRAMATETOPIRAMATEDIRECT RXANDACurrent
61919-691TOPIRAMATETOPIRAMATEDirectRXANDACurrent
63187-228TopiramateTopiramateProficient Rx LPANDACurrent
63187-228TopiramateTopiramateProficient Rx LPANDACurrent
63187-228TopiramateTopiramateProficient Rx LPANDACurrent
63629-3995TopiramatetopiramateBryant Ranch PrepackANDACurrent
68387-558TopiramateTOPIRAMATEKeltman Pharmaceuticals Inc.ANDACurrent
68387-559TopiramateTOPIRAMATEKeltman Pharmaceuticals Inc.ANDACurrent
68387-560TopiramateTOPIRAMATEKeltman Pharmaceuticals Inc.ANDACurrent
68788-6435TopiramateTopiramatePreferred PharmaceuticalsANDACurrent
68788-8965TopiramateTopiramatePreferred PharmaceuticalsANDACurrent
69097-816TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-816TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-816TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-817TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-817TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-817TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-818TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-818TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-818TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-819TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-819TopiramateTopiramateCipla USA Inc.ANDACurrent
69097-819TopiramateTopiramateCipla USA Inc.ANDACurrent
70518-0517TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
70518-0517TopiramateTopiramateREMEDYREPACK INC.ANDACurrent
71610-193TopiramatetopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-485TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-485TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-486TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-486TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-492TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-492TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-493TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-493TopiramateTopiramateAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-278TopiramateTopiramateEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-279TopiramateTopiramateEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-280TopiramateTopiramateEXELAN PHARMACEUTICALS INC.ANDACurrent
76282-281TopiramateTopiramateEXELAN PHARMACEUTICALS INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44403ORIG2009-04-14
9229ORIG2009-04-03