FDA.report

Application 040284

Type
ANDA
Sponsor
LUPIN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENADRINE CITRATEORPHENADRINE CITRATETABLET, EXTENDED RELEASE;ORAL100MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-283Orphenadrine CitrateOrphenadrine CitrateBlenheim Pharmacal, Inc.ANDACurrent
21695-099Orphenadrine CitrateOrphenadrine CitrateRebel Distributors CorpANDACurrent
33261-088Orphenadrine CitrateOrphenadrine CitrateAidarex Pharmaceuticals LLCANDACurrent
33358-274Orphenadrine CitrateOrphenadrine CitrateRxChange Co.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43386-480ORPHENADRINE CITRATEORPHENADRINE CITRATELupin Pharmaceuticals, Inc.ANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA QuaANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50436-7601Orphenadrine CitrateORPHENADRINE CITRATEUnit Dose ServicesANDACurrent
53002-5430ORPHENADRINE CITRATEORPHENADRINE CITRATERPK Pharmaceuticals, Inc.ANDACurrent
60760-810Orphenadrine CitrateOrphenadrine CitrateSt. Mary's Medical Park PharmacyANDACurrent
60760-810Orphenadrine CitrateOrphenadrine CitrateSt. Mary's Medical Park PharmacyANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect RXANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-507ORPHENADRINE CITRATEORPHENADRINE CITRATEDIRECT RXANDACurrent
61919-507ORPHENADRINE CITRATEORPHENADRINE CITRATEDIRECT RXANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63629-1564Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch PrepackANDACurrent
63629-1564Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch PrepackANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66336-554Orphenadrine CitrateOrphenadrine CitrateDispensing Solutions, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9150Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, IncANDACurrent
70934-952ORPHENADRINE CITRATEORPHENADRINE CITRATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
80425-0117NorflexOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0117Orphenadrine CitrateOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0117Orphenadrine CitrateOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
7605ORIG1998-06-19