NDA 18932, held by Teva Womens. Naltrexone Hydrochloride.
As of Nov 14, 2026, NDA 18932 (Revia), held by Teva Womens, was first approved by FDA on Nov 20, 1984, with 12 approved supplements and 0 published complete response letters.
| Dec 30, 1994 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 20, 1984 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Revia50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Naltrexone Hydrochloride | DiscontinuedReference drug |
| Oct 3, 2013 | Supplement 17Labeling | Approved | |
| May 15, 2001 | Supplement 15Labeling · Standard review | Approved | None posted |
| Mar 5, 1999 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 5, 1999 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 23, 1995 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Dec 30, 1994 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 30, 1994 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 2, 1989 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 28, 1987 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jan 28, 1986 | Supplement 3Labeling | Approved | None posted |
| Feb 8, 1985 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1984 | Supplement 1Labeling | Approved | None posted |
| Nov 20, 1984 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
