Dihydroergotamine Mesylate

ANDA 207264, held by Sagent Pharms Inc. Dihydroergotamine Mesylate.

As of Nov 15, 2026, ANDA 207264 (Dihydroergotamine Mesylate), held by Sagent Pharms Inc, was first approved by FDA on Jul 11, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 11, 2018
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
Jul 11, 2018	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Dec 9, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jul 11, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 207264
Drugs@FDA: Overview at FDA
Company: Sagent 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