Dihydroergotamine Mesylate

ANDA 40475, held by Padagis US. Dihydroergotamine Mesylate.

As of Nov 15, 2026, ANDA 40475 (Dihydroergotamine Mesylate), held by Padagis US, was first approved by FDA on Apr 28, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 28, 2003
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
Apr 28, 2003	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dihydroergotamine Mesylate1MG/ML · injectable;injection	Dihydroergotamine Mesylate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Apr 28, 2003	Original application	Approved	Review

Identifiers

Application: ANDA 40475
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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