Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Apr 12, 2016
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 12, 2016
10 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
325MG;5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 202991
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; HYDROCODONE BITARTRATE
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ANDA 209036 · ABHAI LLC
- 2017HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 209037 · ABHAI LLC
- 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
- 2010HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 040881 · MIKART
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.
