Aspirin / Caffeine / dihydrocodeine Oral Capsule

Brand(s)
Synalgos-DC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Caraco Pharmaceutical Laboratories, Ltd. (2013-05-13)
Oldest Current Product
2008-12-30
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL CAPSULE\ASPIRIN:CAFFEINE:DIHYDROCODEINE
FDAOB
ORAL\CAPSULE\ASPIRIN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Active
ORAL\CAPSULE\ASPIRIN: CAFFEINE: DIHYDROCODEINE BITARTRATE
SPL Moiety
ORAL\CAPSULE\ASPIRIN: CAFFEINE: DIHYDROCODEINE

product(s) by strength(s)

aspirin 356.4 mg / caffeine 30 mg / dihydrocodeine bitartrate 16 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497080419Synalgos-DCNDACaraco Pharma, Inc.2008-12-30ASPIRIN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULENDA0114833e863ce5-936c-4145-b14b-76670e21bdad

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1576640419NDA AUTHORIZED GENERICCaraco Pharmaceutical Laboratories, Ltd.2012-10-01ASPIRIN, CAFFEINE, DIHYDROCODEINE BITARTRATEORALCAPSULENDA0114835add9c2f-421d-44ec-952d-95c3ff0a31e4

application(s)

#idtitleapplicantapprovedapproved drug
1NDA011483SYNALGOS-DCSUN PHARMACEUTICAL INDUSTRIES INC1983-09-06NDA011483_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA011483_004RXASPIRIN (356.4MG), DIHYDROCODEINE BITARTRATE (16MG), CAFFEINE (30MG)ORALCAPSULETrue1983-09-06SYNALGOS-DC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13e863ce5-936c-4145-b14b-76670e21bdad (view SPL)Synalgos-DC (Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USP) CIII Rx OnlyprescriptionHuman PrescriptionCaraco Pharma, Inc.ANALYSIS, MANUFACTURE, PACK2013-05-133497080419
25add9c2f-421d-44ec-952d-95c3ff0a31e4 (view SPL)Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USPCIII Rx onlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2013-05-132576640419

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