ANDA 84294, held by Chartwell Rx. Caffeine; Ergotamine Tartrate.
As of Nov 15, 2026, ANDA 84294 (Cafergot), held by Chartwell Rx, was first approved by FDA on Sep 29, 1976, with 18 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cafergot100MG;1MG ยท tablet;oral | Caffeine; Ergotamine Tartrate | DiscontinuedReference drug |
| Apr 14, 2008 | Supplement 83Labeling | Approved | None posted |
| Oct 3, 2003 | Supplement 75Labeling | Approved | None posted |
| Jul 26, 1999 | Supplement 72Manufacturing | Approved | None posted |
| Jan 24, 1994 | Supplement 71Manufacturing | Approved | None posted |
| Feb 3, 1987 | Supplement 70Manufacturing | Approved | None posted |
| Feb 3, 1987 | Supplement 69Manufacturing | Approved | None posted |
| Feb 5, 1986 | Supplement 68Manufacturing | Approved | None posted |
| Dec 17, 1984 | Supplement 67Manufacturing | Approved | None posted |
| Oct 3, 1984 | Supplement 65Manufacturing | Approved | None posted |
| Oct 3, 1984 | Supplement 64Manufacturing | Approved | None posted |
| Jul 26, 1984 | Supplement 66Manufacturing | Approved | None posted |
| Sep 9, 1983 | Supplement 63Manufacturing | Approved | None posted |
| Jul 18, 1983 | Supplement 61Manufacturing | Approved | None posted |
| Jun 6, 1983 | Supplement 60Manufacturing | Approved | None posted |
| Mar 24, 1983 | Supplement 58Manufacturing | Approved | None posted |
| Jul 1, 1982 | Supplement 53Manufacturing | Approved | None posted |
| Jul 1, 1982 | Supplement 52Manufacturing | Approved | None posted |
| Jul 1, 1982 | Supplement 51Manufacturing | Approved | None posted |
| Sep 29, 1976 | Original application | 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
