FDA Orange Book · active-ingredient family
Aspirin; oxycodone hydrochloride; oxycodone terephthalate
Aspirin; oxycodone hydrochloride; oxycodone terephthalate is approved as 1 brand and 6 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)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERCODAN×2 | ENDO OPERATIONS | NDA 007337 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | SUN PHARM INDUSTRIES | ANDA 040260 | — | Jul 17, 1998 | |
| OXYCODONE AND ASPIRIN | ANI PHARMS | ANDA 040255 | — | Feb 27, 1998 | |
| CODOXY | HALSEY | ANDA 087464 | — | Jul 01, 1982 | |
| OXYCODONE AND ASPIRIN (HALF-STRENGTH) | ROXANE | ANDA 087742 | — | Jun 04, 1982 | |
| ROXIPRIN | ROXANE | ANDA 087743 | — | Jun 04, 1982 | |
| OXYCODONE AND ASPIRIN | SUN PHARM INDUSTRIES | ANDA 087794 | — | May 26, 1982 |
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; oxycodone terephthalate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
