Treats migraine headaches with or without aura and the acute treatment of cluster…. ANDA 212046, held by Milla Pharms. Dihydroergotamine Mesylate.
As of Nov 15, 2026, ANDA 212046 (Dihydroergotamine Mesylate), held by Milla Pharms, was first approved by FDA on Jan 7, 2020, with 2 approved supplements 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 |
|---|---|---|---|
| Jan 7, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dihydroergotamine Mesylate1MG/ML · injectable;injection | Dihydroergotamine Mesylate | Rx |
| Aug 28, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 28, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 7, 2020 | 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
