FDA Orange Book · active-ingredient family
Naloxone hydrochloride; pentazocine hydrochloride
Naloxone hydrochloride; pentazocine 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:TALWIN NX · NDA 018733
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TALWIN NX | SANOFI AVENTIS US | NDA 018733 | — | Dec 16, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | LUPIN | ANDA 075735 | AB | Jul 11, 2001 | |
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | SUN PHARM INDS LTD | ANDA 075523 | AB | Mar 17, 2000 | |
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | WATSON LABS | ANDA 074736 | AB | Jan 21, 1997 |
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.
Naloxone hydrochloride; pentazocine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
