Treats migraine headaches with or without aura. ANDA 216881, held by Rubicon Research. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 216881 (Dihydroergotamine Mesylate), held by Rubicon Research, was first approved by FDA on Jun 22, 2023, 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 |
|---|---|---|---|
| Jun 22, 2023 | 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
