Pramipexole Dihydrochloride

ANDA 90190, held by Sandoz. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 90190 (Pramipexole Dihydrochloride), held by Sandoz, was first approved by FDA on Oct 8, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2010
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Oct 8, 2010	Original application	Approved	None posted
Jul 6, 2010	Original application	Approved	None posted

Products

6 strengths and forms


Pramipexole Dihydrochloride0.125MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.25MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.5MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1.5MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.75MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 11, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Oct 26, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Aug 19, 2013	Supplement 12Labeling · Standard review	Approved	None posted
Aug 19, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Sep 29, 2011	Supplement 3Labeling	Approved	None posted
Oct 8, 2010	Original application	Approved	None posted
Jul 6, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90190
Drugs@FDA: Overview at FDA
Company: Sandoz

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