Dihydroergotamine Mesylate

ANDA 214105, held by Amneal. Dihydroergotamine Mesylate.

As of Nov 15, 2026, ANDA 214105 (Dihydroergotamine Mesylate), held by Amneal, was first approved by FDA on Jan 4, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 4, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 4, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dihydroergotamine Mesylate0.5MG/SPRAY · spray, metered;nasal	Dihydroergotamine Mesylate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 28, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jan 4, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 214105
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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