FDA.reportPublic FDA data

Application 090495

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-040Sumatriptan SuccinateSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-040Sumatriptan SuccinateSumatriptan SuccinateNorthStar Rx LLCANDACurrent
55111-693Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-693Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-693Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
55111-693Sumatriptan SuccinateSumatriptan SuccinateDr. Reddy's Laboratories LimitedANDACurrent
70518-3179Sumatriptan SuccinateSumatriptan SuccinateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22710ORIG2016-07-29