Pergolide Mesylate

ANDA 76061, held by Strides Pharma. Pergolide Mesylate.

As of Nov 15, 2026, ANDA 76061 (Pergolide Mesylate), held by Strides Pharma, was first approved by FDA on Nov 27, 2002, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 27, 2002
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
Nov 27, 2002	Original application	Approved	Review

Products

3 strengths and forms


Pergolide MesylateEQ 0.05MG BASE · tablet;oral	Pergolide Mesylate	Discontinued
Pergolide MesylateEQ 0.25MG BASE · tablet;oral	Pergolide Mesylate	Discontinued
Pergolide MesylateEQ 1MG BASE · tablet;oral	Pergolide Mesylate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 8, 2004	Supplement 2Labeling	Approved	None posted
Nov 27, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 76061
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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