FDA Orange Book · active-ingredient family
Naltrexone hydrochloride
Naltrexone 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:REVIA · NDA 018932
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REVIARLD | TEVA WOMENS | NDA 018932 | — | Nov 20, 1984 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALTREXONE HYDROCHLORIDE | CHARTWELL | ANDA 207905 | AB | Jul 21, 2017 | |
| NALTREXONE HYDROCHLORIDE | SUN PHARM | ANDA 090356 | AB | Feb 24, 2012 | |
| NALTREXONE HYDROCHLORIDE | ACCORD HLTHCARE | ANDA 091205 | AB | Aug 17, 2011 | |
| NALTREXONE HYDROCHLORIDE×3 | SPECGX LLC | ANDA 076264 | — | Mar 22, 2002 | |
| NALTREXONE HYDROCHLORIDE | NOVITIUM PHARMA | ANDA 075434 | — | Mar 08, 2000 | |
| NALTREXONE HYDROCHLORIDE | ELITE LABS | ANDA 075274 | AB | May 26, 1999 | |
| NALTREXONE HYDROCHLORIDE | BARR | ANDA 074918 | AB | May 08, 1998 |
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.
Naltrexone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
