Gerimal

ANDA 86188, held by Watson Labs. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 86188 (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
Gerimal1MG · tablet;sublingual	Ergoloid Mesylates	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jan 31, 1997	Supplement 26Manufacturing	Approved	None posted
Nov 25, 1988	Supplement 25Labeling	Approved	None posted
Sep 2, 1988	Supplement 24Labeling	Approved	None posted
Jul 18, 1988	Supplement 23Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 17Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 19Manufacturing	Approved	None posted
Apr 30, 1986	Supplement 20Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 14Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 15Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 16Manufacturing	Approved	None posted
Mar 16, 1984	Supplement 5Manufacturing	Approved	None posted
Jul 7, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 86188
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