Permax

NDA 19385, held by Valeant Pharm Intl. Pergolide Mesylate.

As of Nov 14, 2026, NDA 19385 (Permax), held by Valeant Pharm Intl, was first approved by FDA on Dec 30, 1988, with 30 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1988
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Dec 30, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


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

All 31 submissions, including labeling and manufacturing supplements


Oct 2, 2003	Supplement 35Labeling · Priority review	Approved	Review Label Letter
Oct 2, 2003	Supplement 31Labeling · Priority review	Approved	Review Label Letter
Oct 2, 2003	Supplement 30Labeling · Priority review	Approved	Label Letter
Aug 29, 2002	Supplement 28Labeling · Priority review	Approved	Letter
May 17, 2002	Supplement 32Manufacturing · Priority review	Approved	None posted
Dec 7, 2000	Supplement 29Manufacturing · Priority review	Approved	None posted
Oct 6, 1999	Supplement 26Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 20Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 19Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 17Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 16Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 8Labeling · Priority review	Approved	None posted
Oct 6, 1999	Supplement 4Labeling · Priority review	Approved	None posted
Oct 1, 1999	Supplement 27Manufacturing · Priority review	Approved	None posted
Apr 13, 1999	Supplement 25Manufacturing · Priority review	Approved	None posted
Jun 26, 1998	Supplement 24Manufacturing · Priority review	Approved	None posted
Apr 13, 1998	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 3, 1998	Supplement 21Manufacturing · Priority review	Approved	None posted
Dec 15, 1994	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 15, 1994	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 15, 1994	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 29, 1994	Supplement 14Manufacturing · Priority review	Approved	None posted
Jan 11, 1993	Supplement 10Manufacturing · Priority review	Approved	None posted
Jan 11, 1993	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 8, 1993	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 8, 1993	Supplement 5Manufacturing · Priority review	Approved	None posted
May 15, 1991	Supplement 6Manufacturing · Priority review	Approved	None posted
Nov 27, 1989	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 2, 1989	Supplement 2Labeling · Priority review	Approved	None posted
Mar 17, 1989	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 30, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19385
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

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