FDA Orange Book · active-ingredient family
Aspirin; oxycodone hydrochloride
Aspirin; oxycodone hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PERCODAN · NDA 007337
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERCODANRLD | ENDO OPERATIONS | NDA 007337 | — | Aug 05, 2005 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | EPIC PHARMA LLC | ANDA 040910 | — | Jul 16, 2020 | |
| OXYCODONE AND ASPIRIN | ACTAVIS LABS FL INC | ANDA 090084 | — | Mar 22, 2011 | |
| OXYCODONE AND ASPIRIN | DR REDDYS LABS SA | ANDA 091670 | — | Mar 16, 2011 |
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.
Aspirin; oxycodone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

