FDA Orange Book · active-ingredient family
Acetaminophen; propoxyphene hydrochloride
Acetaminophen; propoxyphene hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DARVOCET · NDA 016844
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARVOCET | AAIPHARMA LLC | NDA 016844 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN | VINTAGE PHARMS | ANDA 040507 | — | Jul 30, 2003 | |
| PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN | WATSON LABS | ANDA 040139 | — | Dec 16, 1996 | |
| PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN | SANDOZ | ANDA 089959 | — | Jul 18, 1989 | |
| DOLENE AP-65 | LEDERLE | ANDA 085100 | — | Approved Prior to Jan 1, 1982 | |
| PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN | MYLAN | ANDA 083689 | — | Approved Prior to Jan 1, 1982 | |
| PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN | MYLAN | ANDA 083978 | — | Approved Prior to Jan 1, 1982 | |
| WYGESIC | CARACO | ANDA 084999 | — | Approved Prior to Jan 1, 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.
Acetaminophen; propoxyphene hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
