Pramipexole Dihydrochloride

ANDA 90764, held by Natco Pharma. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 90764 (Pramipexole Dihydrochloride), held by Natco Pharma, was first approved by FDA on Apr 9, 2010, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 9, 2010
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 9, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pramipexole Dihydrochloride0.75MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 16, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Mar 19, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Mar 19, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Mar 19, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Mar 19, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Aug 8, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Apr 9, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90764
Drugs@FDA: Overview at FDA
Company: Natco Pharma

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