FDA.reportPublic FDA data

Application 040368

Type
ANDA
Sponsor
IMPAX PHARMS

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
0115-2011Orphenadrine CitrateORPHENADRINE CITRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2011Orphenadrine CitrateORPHENADRINE CITRATEImpax GenericsANDACurrent
0115-2011Orphenadrine CitrateORPHENADRINE CITRATEAmneal Pharmaceuticals of New York LLCANDACurrent
50090-3150Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50090-3150Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
52959-527Orphenadrine CitrateORPHENADRINE CITRATEH.J. Harkins Company, Inc.ANDACurrent
68084-820Orphenadrine CitrateORPHENADRINE CITRATEAmerican Health PackagingANDACurrent
68084-820Orphenadrine CitrateORPHENADRINE CITRATEAmerican Health PackagingANDACurrent
68084-820Orphenadrine CitrateORPHENADRINE CITRATEAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7639ORIG2000-06-23