FDA.reportPublic FDA data

Application 075141

Type
ANDA
Sponsor
GALT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENGESICASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL385MG;30MG;25MGNoNo
002ORPHENGESIC FORTEASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL770MG;60MG;50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-305NorgesicOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-999Orphengesic ForteOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-999Orphengesic ForteOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
71993-304Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-304Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-999Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-999Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
74157-999Orphenadrine Citrate, Aspirin and Caffeineorphenadrine citrate, aspirin and caffeineINA Pharmaceutics, IncANDACurrent
74157-999Orphenadrine Citrate, Aspirin and Caffeineorphenadrine citrate, aspirin and caffeineINA Pharmaceutics, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22431ORIG1998-05-29