FDA.reportPublic FDA data

Application 074988

Type
ANDA
Sponsor
STEVENS J

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINEASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL385MG;30MG;25MGNoNo
002ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINEASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL770MG;60MG;50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50564-554Orphenadrine Citrate Aspirin CaffeineOrphenadrine Citrate, Aspirin, CaffeineJerome Stevens Pharmaceuticals, Inc.ANDACurrent
50564-555Orphenadrine Citrate Aspirin CaffeineOrphenadrine Citrate, Aspirin, CaffeineJerome Stevens Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8481ORIG1999-04-30