Orange Book product · Generic (ANDA)
OXYCODONE HYDROCHLORIDE AND IBUPROFEN
IBUPROFEN; OXYCODONE HYDROCHLORIDE
Generic (ANDA)ANDA 078394DISCN WATSON LABS
At a glance
Nov 26, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 2007
18 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
IBUPROFEN; OXYCODONE HYDROCHLORIDE
Strength
400MG;5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 078394
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IBUPROFEN; OXYCODONE HYDROCHLORIDE
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.
