FDA.report

Application 078284

Type
ANDA
Sponsor
ORCHID HLTHCARE

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-531SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
16714-531SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
16714-532SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
16714-532SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
16714-533SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
16714-533SumatriptanSumatriptanNorthstar Rx LLCANDACurrent
42043-220SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-220SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-220SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-221SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-221SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-221SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-222SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-222SumatriptanSumatriptanOrchidPharma IncANDACurrent
42043-222SumatriptanSumatriptanOrchidPharma IncANDACurrent
53002-3562SumatriptanSumatriptanRPK Pharmaceuticals, Inc.ANDACurrent
55700-918SumatriptanSumatriptanQuality Care Products, LLCANDACurrent
55700-969SumatriptanSumatriptanQuality Care Products, LLCANDACurrent
68071-2825SumatriptanSumatriptanNuCare Pharmaceuticals,Inc.ANDACurrent
69452-344SumatriptanSumatriptanBionpharma Inc.ANDACurrent
69452-345SumatriptanSumatriptanBionpharma Inc.ANDACurrent
69452-346SumatriptanSumatriptanBionpharma Inc.ANDACurrent
72189-404ImitrexSumatriptanDirect_RxANDACurrent

Documents

DocumentSubmission typeDate
31353ORIG2009-08-14