Treats migraine headaches with or without aura. ANDA 215228, held by Somerset Theraps LLC. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 215228 (Dihydroergotamine Mesylate), held by Somerset Theraps LLC, was first approved by FDA on Feb 26, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate0.5MG/SPRAY · spray, metered;nasal | 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
