Treats migraine headaches with or without aura and the acute treatment of cluster…. ANDA 40453, held by Hikma. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 40453 (Dihydroergotamine Mesylate), held by Hikma, was first approved by FDA on Jun 9, 2003, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate1MG/ML · injectable;injection | Dihydroergotamine Mesylate | Rx |
| Feb 8, 2023 | Supplement 9Manufacturing | Approved | None posted |
| Jun 9, 2003 | Original application | Approved |
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
