Treats migraine headaches with or without aura and the acute treatment of cluster…. ANDA 206621, held by Hikma Pharms. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 206621 (Dihydroergotamine Mesylate), held by Hikma Pharms, was first approved by FDA on Sep 15, 2017, 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 |
|---|---|---|---|
| Sep 15, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate1MG/ML · injectable;injection | Dihydroergotamine Mesylate | Rx |
| Feb 15, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 15, 2017 | 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
