Aspirin / Caffeine / Orphenadrine Oral Tablet

Brand(s)
Norgesic
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
1964-03-04
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ASPIRIN:CAFFEINE:ORPHENADRINE
FDAOB
ORAL\TABLET\ASPIRIN: CAFFEINE: ORPHENADRINE CITRATE
SPL Active
ORAL\TABLET, MULTILAYER\ASPIRIN: CAFFEINE: ORPHENADRINE CITRATE
SPL Moiety
ORAL\TABLET, MULTILAYER\ASPIRIN: CAFFEINE: ORPHENADRINE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000890231NorgesicNDA3M Pharmaceuticals1964-03-042015-12-31ASPIRIN, CAFFEINE, ORPHENADRINE CITRATEORALTABLET, MULTILAYERNDA013416a7fa86b5-2154-4b17-9265-8a5411c88d5d

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000890233NorgesicNDA3M Pharmaceuticals1964-03-042015-12-31ASPIRIN, CAFFEINE, ORPHENADRINE CITRATEORALTABLET, MULTILAYERNDA013416a7fa86b5-2154-4b17-9265-8a5411c88d5d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950726ANDARebel Distributors Corp1996-12-31ASPIRIN, CAFFEINE, ORPHENADRINE CITRATEORALTABLET, MULTILAYER001850714ANDA0746548e41b33e-f71f-4a5e-b88f-cdfefb2bee20

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074654ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINESANDOZ INC1996-12-31ANDA074654_001, ANDA074654_002
2ANDA074817INVAGESICTrueSANDOZ INC1996-11-27ANDA074817_001, ANDA074817_002
3ANDA074988ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINETrueJEROME STEVENS PHARMACEUTICALS INC1999-04-30ANDA074988_001, ANDA074988_002
4ANDA075141ORPHENGESICTruePRINSTON PHARMACEUTICAL INC1998-05-29ANDA075141_001, ANDA075141_002
5NDA013416NORGESICTrueMEDICIS PHARMACEUTICAL CORP1982-10-27NDA013416_003, NDA013416_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074654_001RXASPIRIN (385MG), ORPHENADRINE CITRATE (25MG), CAFFEINE (30MG)ORALTABLETFalse1996-12-31ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
2ANDA074654_002RXASPIRIN (770MG), ORPHENADRINE CITRATE (50MG), CAFFEINE (60MG)ORALTABLETTrue1996-12-31ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
3ANDA074817_001discontinuedORPHENADRINE CITRATE (25MG), CAFFEINE (30MG), ASPIRIN (385MG)ORALTABLETFalse1996-11-27INVAGESIC
4ANDA074817_002discontinuedORPHENADRINE CITRATE (50MG), ASPIRIN (770MG), CAFFEINE (60MG)ORALTABLETFalse1996-11-27INVAGESIC
5ANDA074988_001discontinuedASPIRIN (385MG), CAFFEINE (30MG), ORPHENADRINE CITRATE (25MG)ORALTABLETFalse1999-04-30ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
6ANDA074988_002discontinuedASPIRIN (770MG), ORPHENADRINE CITRATE (50MG), CAFFEINE (60MG)ORALTABLETFalse1999-04-30ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
7ANDA075141_001discontinuedCAFFEINE (30MG), ORPHENADRINE CITRATE (25MG), ASPIRIN (385MG)ORALTABLETFalse1998-05-29ORPHENGESIC
8ANDA075141_002discontinuedCAFFEINE (60MG), ASPIRIN (770MG), ORPHENADRINE CITRATE (50MG)ORALTABLETFalse1998-05-29ORPHENGESIC
9NDA013416_003discontinuedASPIRIN (385MG), CAFFEINE (30MG), ORPHENADRINE CITRATE (25MG)ORALTABLETFalse1982-10-27NORGESIC
10NDA013416_004discontinuedORPHENADRINE CITRATE (50MG), ASPIRIN (770MG), CAFFEINE (60MG)ORALTABLETFalse1982-10-27NORGESIC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18e41b33e-f71f-4a5e-b88f-cdfefb2bee20 (view SPL)Orphenadrine Citrate, Aspirin and Caffeine TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-221216950726
2a7fa86b5-2154-4b17-9265-8a5411c88d5d (view SPL)Norgesic AND Norgesic ForteprescriptionHuman Prescription3M Pharmaceuticals2006-05-114000890231, 000890233

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII