Hydergine

NDA 18418, held by Novartis. Ergoloid Mesylates.

As of Nov 13, 2026, NDA 18418 (Hydergine), held by Novartis, was first approved by FDA on Jan 30, 1981, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1981
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 30, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydergine1MG/ML · solution;oral	Ergoloid Mesylates	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 10, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 12, 1998	Supplement 17Labeling · Standard review	Approved	None posted
Feb 28, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
May 26, 1987	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 27, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 13, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 26, 1983	Supplement 7Labeling · Standard review	Approved	None posted
Mar 24, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 3, 1983	Supplement 4Labeling · Standard review	Approved	None posted
Nov 23, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 30, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18418
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