Treats migraine headaches with or without aura and the acute treatment of cluster…. ANDA 215623, held by Gland. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 215623 (Dihydroergotamine Mesylate), held by Gland, was first approved by FDA on Aug 18, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Dihydroergotamine Mesylate Injection 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 |
|---|---|---|---|
| Aug 18, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate1MG/ML · injectable;injection | Dihydroergotamine Mesylate | Rx |
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
