Ergoloid Mesylates

ANDA 87552, held by Sun Pharm Industries. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 87552 (Ergoloid Mesylates), held by Sun Pharm Industries, was first approved by FDA on Aug 11, 1981, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1981
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 11, 1981	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 19Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 18Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 17Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 14Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 16Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 13Labeling	Approved	None posted
Mar 31, 1987	Supplement 10Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 4Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 5Manufacturing	Approved	None posted
Dec 5, 1985	Supplement 6Manufacturing	Approved	None posted
Nov 2, 1983	Supplement 3Manufacturing	Approved	None posted
Oct 4, 1983	Supplement 1Manufacturing	Approved	None posted
Aug 11, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87552
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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