Treats migraine headaches with or without aura. ANDA 212907, held by Cipla. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 212907 (Dihydroergotamine Mesylate), held by Cipla, was first approved by FDA on May 20, 2020, with 1 approved supplement 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 |
|---|---|---|---|
| May 20, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate0.5MG/SPRAY · spray, metered;nasal | Dihydroergotamine Mesylate | Rx |
| Sep 12, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 20, 2020 | 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
