FDA.reportPublic FDA data

Application 040249

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENADRINE CITRATEORPHENADRINE CITRATETABLET, EXTENDED RELEASE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69784-905Orphenadrine CitrateOrphenadrine CitrateWoodward Pharma Services LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38871ORIG2004-06-10
22104ORIG2003-07-30
7590ORIG1999-01-29