ANDA 40590, held by Pharmobedient. Caffeine; Ergotamine Tartrate.
As of Nov 15, 2026, ANDA 40590 (Ergotamine Tartrate And Caffeine), held by Pharmobedient, was first approved by FDA on Sep 16, 2005, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ergotamine Tartrate And Caffeine100MG;1MG · tablet;oral | Caffeine; Ergotamine Tartrate | Rx |
| Jun 14, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 14, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 16, 2005 | 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
