Migranal

Treats migraine headaches with or without aura. NDA 20148, held by Bausch. Dihydroergotamine Mesylate.

As of Nov 13, 2026, NDA 20148 (Migranal), held by Bausch, was first approved by FDA on Dec 8, 1997, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 8, 1997
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 8, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Migranal0.5MG/SPRAY · spray, metered;nasal	Dihydroergotamine Mesylate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 9, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Aug 1, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 14, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 31, 2002	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 31, 2002	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 4, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 5, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 31, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 2, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 30, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 19, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 30, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 26, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 8, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20148
Drugs@FDA: Overview at FDA
Company: Bausch Health

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