D.H.E. 45

NDA 5929, held by Bausch. Dihydroergotamine Mesylate.

As of Nov 13, 2026, NDA 5929 (D.H.E. 45), held by Bausch, was first approved by FDA on Apr 12, 1946, with 26 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1946
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Apr 12, 1946	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
D.H.E. 451MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dihydroergotamine Mesylate	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


May 9, 2022	Supplement 45Labeling · Standard review	Approved	Label Letter
Sep 1, 2009	Supplement 44Manufacturing	Approved	Label
Jul 31, 2002	Supplement 33Labeling · Standard review	Approved	Letter Label
Jul 31, 2002	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 4, 2001	Supplement 40Manufacturing	Approved	None posted
Oct 3, 2001	Supplement 39Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 38Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 36Manufacturing	Approved	None posted
Sep 19, 2000	Supplement 37Manufacturing	Approved	None posted
May 16, 2000	Supplement 34Manufacturing	Approved	None posted
Jan 19, 1999	Supplement 31Manufacturing	Approved	None posted
Jan 29, 1998	Supplement 25Labeling · Standard review	Approved	None posted
Jan 29, 1998	Supplement 19Labeling	Approved	None posted
Mar 7, 1997	Supplement 29Manufacturing	Approved	None posted
Aug 10, 1995	Supplement 28Manufacturing	Approved	None posted
May 23, 1994	Supplement 26Labeling · Standard review	Approved	None posted
Mar 9, 1993	Supplement 18Manufacturing	Approved	None posted
Jul 7, 1992	Supplement 16Manufacturing	Approved	None posted
Apr 4, 1990	Supplement 15Manufacturing	Approved	None posted
Sep 22, 1989	Supplement 14Manufacturing	Approved	None posted
Dec 2, 1988	Supplement 8Manufacturing	Approved	None posted
Jan 8, 1987	Supplement 6Manufacturing	Approved	None posted
Oct 24, 1983	Supplement 7Manufacturing	Approved	None posted
Sep 15, 1982	Supplement 5Manufacturing	Approved	None posted
Jan 27, 1981	Supplement 4Manufacturing	Approved	None posted
May 31, 1979	Supplement 3Manufacturing	Approved	None posted
Apr 12, 1946	Original application	Approved	None posted

Identifiers

Application: NDA 5929
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