FDA.reportPublic FDA data

Application 040327

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENADRINE CITRATEORPHENADRINE CITRATETABLET, EXTENDED RELEASE;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0022Orphenadrine CitrateOrphenadrine CitrateEon Labs, Inc.ANDACurrent
0185-0022Orphenadrine CitrateOrphenadrine CitrateEon Labs, Inc.ANDACurrent
0185-0022Orphenadrine CitrateOrphenadrine CitrateEon Labs, Inc.ANDACurrent
45865-363Orphenadrine CitrateOrphenadrine CitrateMedsource PharmaceuticalsANDACurrent
63187-632Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-632Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
68151-1463Orphenadrine CitrateOrphenadrine CitrateCarilion Materials ManagementANDACurrent
68788-9306Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0117Orphenadrine CitrateOrphenadrine CitrateBryant Ranch PrepackANDACurrent
71335-0117Orphenadrine CitrateOrphenadrine CitrateBryant Ranch PrepackANDACurrent
71335-0117Orphenadrine CitrateOrphenadrine CitrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29929ORIG2000-02-15