ANDA 40510, held by Hikma. Caffeine; Ergotamine Tartrate.
As of Nov 15, 2026, ANDA 40510 (Ergotamine Tartrate And Caffeine), held by Hikma, was first approved by FDA on Sep 17, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ergotamine Tartrate And Caffeine100MG;1MG ยท tablet;oral | Caffeine; Ergotamine Tartrate | Discontinued |
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
