Ergoloid Mesylates

ANDA 88891, held by Mutual Pharm. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 88891 (Ergoloid Mesylates), held by Mutual Pharm, was first approved by FDA on Nov 1, 1985, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1985
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 1, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ergoloid Mesylates1MG · tablet;oral	Ergoloid Mesylates	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 16Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 15Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 14Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 11Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 13Manufacturing	Approved	None posted
Apr 10, 1989	Supplement 9Labeling	Approved	None posted
Sep 8, 1988	Supplement 10Labeling	Approved	None posted
Jun 5, 1987	Supplement 5Manufacturing	Approved	None posted
Apr 3, 1987	Supplement 7Manufacturing	Approved	None posted
Nov 1, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88891
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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