NDA 9087, held by Novartis. Ergoloid Mesylates.
As of Nov 13, 2026, NDA 9087 (Hydergine), held by Novartis, was first approved by FDA on Nov 5, 1953, with 33 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 1975 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 5, 1953 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydergine1MG · tablet;sublingual | Ergoloid Mesylates | Discontinued |
| Hydergine0.5MG · tablet;sublingual | Ergoloid Mesylates | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2000 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1999 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Nov 12, 1998 | Supplement 45Labeling · Standard review | Approved | None posted |
| Sep 14, 1993 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1993 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1989 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| May 26, 1987 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1983 | Supplement 36Labeling · Standard review | Approved | None posted |
| Aug 26, 1983 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1983 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jan 19, 1983 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1981 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1981 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1981 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1981 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 14, 1978 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 20, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1976 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1976 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 23, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1975 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1975 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1975 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 2, 1975 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 16, 1975 | Supplement 4REMS · Standard review | Approved | None posted |
| Dec 13, 1974 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1974 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1953 | Original applicationNew molecular entity · Standard 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
