Orange Book product · Generic (ANDA)
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Mar 27, 1985
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 27, 1985
41 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
500MG;5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 088898
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; HYDROCODONE BITARTRATE
- 2021HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 201295 · TRIS PHARMA INC
- 2019HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 211023 · WES PHARMA INC
- 2018HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 208540 · ALVOGEN
- 2018HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 209958 · ALVOGEN
- 2017HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 209036 · ABHAI LLC
- 2017HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 209037 · ABHAI LLC
- 2016HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 207137 · AMNEAL PHARMS
- 2016HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 206470 · ACTAVIS LABS FL INC
- 2016ZYFRELGeneric (ANDA)
ANDA 090468 · CYPRESS PHARM INC
- 2013HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 040838 · PHARM ASSOC
- 2012HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 200343 · GENUS
- 2011HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 040894 · GENUS
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.
