FDA Orange Book · active-ingredient family
Acetaminophen; pentazocine hydrochloride
Acetaminophen; pentazocine hydrochloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TALACEN · NDA 018458
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TALACEN | SANOFI AVENTIS US | NDA 018458 | — | Sep 23, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE | GAVIS PHARMS | ANDA 076202 | — | Aug 02, 2002 | |
| ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE | WATSON LABS | ANDA 074699 | — | Mar 24, 2000 |
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; pentazocine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
