Orange Book product · Generic (ANDA)
ROXICET
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
At a glance
Dec 03, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 03, 1986
40 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength
325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 089351
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
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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.
