ANDA 85153, held by Sandoz. Ergoloid Mesylates.
As of Nov 15, 2026, ANDA 85153 (Alkergot), held by Sandoz, was first approved by FDA on Sep 16, 1994, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alkergot0.5MG ยท tablet;sublingual | Ergoloid Mesylates | 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
