Application 076554

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-4622SUMATRIPTANSUMATRIPTANUnit Dose ServicesANDACurrent
50436-4622SUMATRIPTANSUMATRIPTANUnit Dose ServicesANDACurrent
50436-4623SUMATRIPTANSUMATRIPTANUnit Dose ServicesANDACurrent
63187-164SUMATRIPTANSUMATRIPTANProficient Rx LPANDACurrent
63187-164SUMATRIPTANSUMATRIPTANProficient Rx LPANDACurrent
63304-097SUMATRIPTANSUMATRIPTANRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-097SumatriptanSumatriptanSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
63304-098SUMATRIPTANSUMATRIPTANRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-098SumatriptanSumatriptanSUN PHARMACEUTICAL INDUSTRIES, INC.ANDACurrent
68788-9308SUMATRIPTANSUMATRIPTANPreferred PharmaceuticalsANDACurrent
68788-9798SUMATRIPTANSUMATRIPTANPreferred PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8924ORIG2009-08-14