NDA 17857, held by Apothecon. Butorphanol Tartrate.
As of Nov 13, 2026, NDA 17857 (Stadol Preservative Free, Stadol), held by Apothecon, was first approved by FDA on Aug 22, 1978, with 44 approved supplements and 0 published complete response letters.
| Mar 5, 1987 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 26, 1982 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 22, 1978 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Stadol Preservative Free1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Butorphanol Tartrate | DiscontinuedReference drug |
| Stadol Preservative Free2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Butorphanol Tartrate | DiscontinuedReference drug |
| Stadol2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Butorphanol Tartrate | DiscontinuedReference drug |
| Nov 5, 2001 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| May 25, 1999 | Supplement 54Labeling · Priority review | Approved | None posted |
| Mar 13, 1998 | Supplement 53Labeling · Priority review | Approved | None posted |
| Mar 13, 1998 | Supplement 51Labeling · Priority review | Approved | None posted |
| Apr 16, 1993 | Supplement 50Labeling · Priority review | Approved | None posted |
| Apr 16, 1993 | Supplement 49Labeling · Priority review | Approved | None posted |
| May 1, 1992 | Supplement 48Labeling · Priority review | Approved | None posted |
| Sep 19, 1990 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1988 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Aug 4, 1987 | Supplement 43Labeling · Priority review | Approved | None posted |
| Aug 4, 1987 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Aug 4, 1987 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Mar 5, 1987 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 14, 1987 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1986 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Jul 22, 1985 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jan 10, 1985 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1984 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 19, 1984 | Supplement 35Labeling · Priority review | Approved | None posted |
| Jun 7, 1984 | Supplement 34Labeling · Priority review | Approved | None posted |
| Jun 7, 1984 | Supplement 33Labeling · Priority review | Approved | None posted |
| May 9, 1984 | Supplement 32Labeling · Priority review | Approved | None posted |
| May 7, 1984 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Apr 16, 1984 | Supplement 31Labeling · Priority review | Approved | None posted |
| Apr 4, 1984 | Supplement 30Labeling · Priority review | Approved | None posted |
| Jan 17, 1984 | Supplement 26Labeling · Priority review | Approved | None posted |
| Sep 7, 1983 | Supplement 25Labeling · Priority review | Approved | None posted |
| Apr 20, 1983 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 20, 1983 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Sep 7, 1982 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1982 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | None posted |
| Sep 2, 1981 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| May 14, 1981 | Supplement 20Labeling · Priority review | Approved | None posted |
| May 14, 1981 | Supplement 19Labeling · Priority review | Approved | None posted |
| Jun 3, 1980 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1979 | Supplement 9Labeling · Priority review | Approved | None posted |
| Nov 20, 1979 | Supplement 7Labeling · Priority review | Approved | None posted |
| Nov 20, 1979 | Supplement 6Labeling · Priority review | Approved | None posted |
| Nov 20, 1979 | Supplement 5Labeling · Priority review | Approved | None posted |
| May 15, 1979 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1978 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1978 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1978 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1978 | Supplement 1Labeling · Priority review | Approved | None posted |
| Aug 22, 1978 | 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
