Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Feb 25, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 25, 2010
16 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
300MG/15ML;10MG/15ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 040881
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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.
