NDA 8720, held by Valeant Pharm Intl. Levorphanol Tartrate.
As of Nov 13, 2026, NDA 8720 (Levo-Dromoran), held by Valeant Pharm Intl, was first approved by FDA on Jan 8, 1953, with 8 approved supplements and 0 published complete response letters.
| Dec 19, 1991 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 8, 1953 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levo-Dromoran2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Levorphanol Tartrate | DiscontinuedReference drug |
| Sep 3, 2004 | Supplement 16Manufacturing · Priority review | Approved | |
| Jan 26, 1998 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Dec 19, 1991 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 25, 1986 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Feb 3, 1983 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Mar 3, 1981 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jun 25, 1979 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1978 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jan 8, 1953 | Original applicationNew dosage form · 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
