Orange Book product · Generic (ANDA)
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
At a glance
Aug 26, 1997
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 1997
29 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Strength
356.4MG;30MG;16MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 040109
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
- 2016ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEGeneric (ANDA)
ANDA 204209 · PHARMOBEDIENT
- 2014TREZIXGeneric (ANDA)
ANDA 204785 · KEY THERAP
- 2007ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATEGeneric (ANDA)
ANDA 040688 · WRASER PHARMS LLC
- 2007ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATEGeneric (ANDA)
ANDA 040701 · BOCA PHARMA LLC
- 2006ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATEGeneric (ANDA)
ANDA 040637 · WEST-WARD PHARM CORP
- 1999ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATEGeneric (ANDA)
ANDA 040316 · MIKART
- 1986SYNALGOS-DC-AGeneric (ANDA)
ANDA 089166 · LEITNER PHARMS
- 1986DHC PLUSGeneric (ANDA)
ANDA 088584 · PHARM RES ASSOC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
