Orange Book product · Generic (ANDA)
OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
At a glance
Jul 02, 2018
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 02, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength
325MG;5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 209385
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- 2014XARTEMIS XRBrand (NDA)
NDA 204031 · MALLINCKRODT INC
- 2021OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 201448 · SANKALP LIFECARE
- 2019OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 211708 · GRANULES
- 2019OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 207834 · CHARTWELL
- 2018OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 211499 · ABHAI LLC
- 2018OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 202142 · MIKART
- 2018OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 203864 · EPIC PHARMA LLC
- 2018OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 210644 · ABHAI LLC
- 2017OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 210079 · NESHER PHARMS
- 2017OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 207333 · LANNETT CO INC
- 2017OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 207419 · ASCENT PHARMS INC
- 2017OXYCODONE AND ACETAMINOPHENGeneric (ANDA)
ANDA 204407 · NOVEL LABS INC
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.
