Hydergine

NDA 17993, held by Novartis. Ergoloid Mesylates.

As of Nov 14, 2026, NDA 17993 (Hydergine), held by Novartis, was first approved by FDA on Dec 30, 1977, with 27 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1977
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Dec 30, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Hydergine1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ergoloid Mesylates	DiscontinuedReference drug
Hydergine0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ergoloid Mesylates	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Apr 2, 2001	Supplement 35Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 34Manufacturing · Standard review	Approved	None posted
May 10, 2000	Supplement 33Manufacturing · Standard review	Approved	None posted
Mar 13, 2000	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 12, 1998	Supplement 27Labeling · Standard review	Approved	None posted
Jun 18, 1996	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 7, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Oct 12, 1995	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 14, 1993	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 7, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
May 26, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 7, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 26, 1983	Supplement 16Labeling · Standard review	Approved	None posted
Feb 3, 1983	Supplement 14Labeling · Standard review	Approved	None posted
Jan 19, 1983	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 15, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 25, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 2, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 10, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 4, 1981	Supplement 4Labeling · Standard review	Approved	None posted
Feb 3, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 11, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 1, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 5, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 30, 1978	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 30, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17993
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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