Gerimal

ANDA 86189, held by Watson Labs. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 86189 (Gerimal), held by Watson Labs, was first approved by FDA on Jul 7, 1980, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 7, 1980
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jul 7, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gerimal0.5MG · tablet;sublingual	Ergoloid Mesylates	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jan 31, 1997	Supplement 24Manufacturing	Approved	None posted
Nov 25, 1988	Supplement 23Labeling	Approved	None posted
Sep 1, 1988	Supplement 22Labeling	Approved	None posted
Jul 18, 1988	Supplement 21Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 17Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 16Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 14Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 13Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 12Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 11Manufacturing	Approved	None posted
Jul 30, 1985	Supplement 4Manufacturing	Approved	None posted
Jul 7, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 86189
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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