FDA.reportPublic FDA data

Application 077744

Type
ANDA
Sponsor
MYLAN

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
0378-5630Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5630Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5630Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5630Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5630Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5631Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5631Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5631Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5631Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5631Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5632Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5632Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5632Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5632Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
0378-5632Sumatriptan Succinatesumatriptan succinateMylan Pharmaceuticals Inc.ANDACurrent
51407-011Sumatriptan Succinatesumatriptan succinateGSMS, IncorporatedANDACurrent
51407-011Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-011Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-011Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-011Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-012Sumatriptan Succinatesumatriptan succinateGSMS, IncorporatedANDACurrent
51407-012Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-012Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-012Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-012Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-013Sumatriptan Succinatesumatriptan succinateGSMS, IncorporatedANDACurrent
51407-013Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-013Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-013Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent
51407-013Sumatriptan Succinatesumatriptan succinateGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31286ORIG2009-08-14