FDA.reportPublic FDA data

Application 078295

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASENoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASENoNo
003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-662sumatriptan succinatesumatriptan succinateAidarex Pharmaceuticals LLCANDACurrent
50090-5939sumatriptan succinatesumatriptan succinateA-S Medication SolutionsANDACurrent
55700-092sumatriptan succinatesumatriptan succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-093sumatriptan succinatesumatriptan succinateLake Erie Medical DBA QuaANDACurrent
55700-093sumatriptan succinatesumatriptan succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-093sumatriptan succinatesumatriptan succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-093sumatriptan succinatesumatriptan succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-846sumatriptan succinatesumatriptan succinateQuality Care Products, LLCANDACurrent
55700-846sumatriptan succinatesumatriptan succinateQuality Care Products, LLCANDACurrent
62756-520sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
62756-520sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
62756-521sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
62756-521sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
62756-522sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
62756-522sumatriptan succinatesumatriptan succinateSun Pharmaceutical Industries, Inc.ANDACurrent
68071-4389sumatriptan succinatesumatriptan succinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4389sumatriptan succinatesumatriptan succinateNuCare Pharmaceuticals,Inc.ANDACurrent
68151-1658sumatriptan succinatesumatriptan succinateCarilion Materials ManagementANDACurrent
68258-7114sumatriptan succinatesumatriptan succinateDispensing Solutions, Inc.ANDACurrent
68788-7158sumatriptan succinatesumatriptan succinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7158sumatriptan succinatesumatriptan succinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7158sumatriptan succinatesumatriptan succinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-8205sumatriptan succinatesumatriptan succinatePreferred Pharmaceuticals Inc.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
70518-1183sumatriptan succinatesumatriptan succinateREMEDYREPACK INC.ANDACurrent
71205-251sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-251sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-251sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-274sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-274sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-274sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-274sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent
71205-725sumatriptan succinatesumatriptan succinateProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9139ORIG2009-08-14