Acetaminophen / Caffeine / dihydrocodeine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2008-05-20
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAMINOPHEN:CAFFEINE:DIHYDROCODEINE
FDAOB
ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Active
ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Moiety
ORAL\TABLET\ACETAMINOPHEN: CAFFEINE: DIHYDROCODEINE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685900ANDAPhysicians Total Care, Inc.2008-05-20ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALTABLET643760611ANDA040701f3ddb645-028a-4c54-96b9-dbfecacf19bb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040316ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATETrueMIKART INC1999-04-28ANDA040316_001
2ANDA040637ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATETrueWEST-WARD PHARMACEUTICAL CORP2006-09-22ANDA040637_001
3ANDA040701ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATETrueBOCA PHARMACAL LLC2007-04-03ANDA040701_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040316_001discontinuedCAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG)ORALTABLETFalse1999-04-28ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
2ANDA040637_001discontinuedCAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG)ORALTABLETFalse2006-09-22ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
3ANDA040701_001discontinuedCAFFEINE (60MG), DIHYDROCODEINE BITARTRATE (32MG), ACETAMINOPHEN (712.8MG)ORALTABLETFalse2007-04-03ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f3ddb645-028a-4c54-96b9-dbfecacf19bb (view SPL)Acetaminophen, Caffeine and Dihydrocodeine Bitartrate TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-11-242548685900

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