Hydrogenated Ergot Alkaloids

ANDA 87185, held by Ivax Pharms. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 87185 (Hydrogenated Ergot Alkaloids), held by Ivax Pharms, was first approved by FDA on Nov 20, 1980, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 20, 1980
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Nov 20, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrogenated Ergot Alkaloids1MG · tablet;sublingual	Ergoloid Mesylates	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 32Manufacturing	Approved	None posted
Jun 27, 2002	Supplement 30Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 31Manufacturing	Approved	None posted
Jul 21, 2000	Supplement 29Manufacturing	Approved	None posted
Jul 21, 2000	Supplement 28Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 27Manufacturing	Approved	None posted
Nov 23, 1999	Supplement 26Manufacturing	Approved	None posted
Aug 20, 1999	Supplement 25Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 24Manufacturing	Approved	None posted
May 30, 1997	Supplement 23Manufacturing	Approved	None posted
Nov 22, 1995	Supplement 22Manufacturing	Approved	None posted
Jun 27, 1995	Supplement 19Manufacturing	Approved	None posted
Aug 24, 1994	Supplement 21Manufacturing	Approved	None posted
May 17, 1990	Supplement 18Labeling	Approved	None posted
Aug 2, 1989	Supplement 17Labeling	Approved	None posted
Aug 22, 1988	Supplement 15Manufacturing	Approved	None posted
Feb 11, 1988	Supplement 16Manufacturing	Approved	None posted
Feb 11, 1988	Supplement 14Manufacturing	Approved	None posted
Feb 11, 1988	Supplement 13Manufacturing	Approved	None posted
Nov 20, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 87185
Drugs@FDA: Overview at FDA
Company: IVAX 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