FDA Orange Book · active-ingredient family
Aspirin; hydrocodone bitartrate
Aspirin; hydrocodone bitartrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ASPIRIN | LGM PHARMA | ANDA 205479 | — | May 28, 2021 | |
| AZDONE | SCHWARZ PHARMA | ANDA 089420 | — | Jan 25, 1988 | |
| VICOPRIN | ABBOTT | ANDA 086333 | — | Sep 14, 1983 |
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; hydrocodone bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
