Ergoloid Mesylates

ANDA 81113, held by Sun Pharm Industries. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 81113 (Ergoloid Mesylates), held by Sun Pharm Industries, was first approved by FDA on Oct 31, 1991, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1991
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
Oct 31, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Apr 9, 2008	Supplement 26Labeling	Approved	None posted
Aug 6, 2002	Supplement 13Manufacturing	Approved	None posted
Jun 11, 2001	Supplement 12Manufacturing	Approved	None posted
Jun 11, 2001	Supplement 11Manufacturing	Approved	None posted
May 16, 2000	Supplement 8Manufacturing	Approved	None posted
May 16, 2000	Supplement 7Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 6Manufacturing	Approved	None posted
Oct 10, 1997	Supplement 5Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 4Manufacturing	Approved	None posted
Aug 9, 1995	Supplement 2Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 3Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 1Manufacturing	Approved	None posted
Oct 31, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81113
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