Ergoloid Mesylates

ANDA 86265, held by Kv Pharm. Ergoloid Mesylates.

As of Nov 15, 2026, ANDA 86265 (Ergoloid Mesylates), held by Kv Pharm, was first approved by FDA on Jan 8, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 8, 1981
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 8, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ergoloid Mesylates0.5MG · tablet;sublingual	Ergoloid Mesylates	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 12, 1988	Supplement 3Labeling	Approved	None posted
Jan 8, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86265
Drugs@FDA: Overview at FDA
Company: KV Pharmaceutical

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