Pramipexole Dihydrochloride

Treats Parkinson's disease. ANDA 90865, held by Torrent Pharms. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 90865 (Pramipexole Dihydrochloride), held by Torrent Pharms, was first approved by FDA on Oct 8, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2010
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson's disease (PD) Moderate-to-severe primary Restless Legs Syndrome (RLS) 1.1 Parkinson’s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 8, 2010	Original application	Approved	None posted

Products

6 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Jul 26, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Jul 26, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Oct 13, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 13, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Oct 13, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Dec 10, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Oct 31, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Aug 29, 2011	Supplement 2Labeling	Approved	None posted
Aug 22, 2011	Supplement 1Manufacturing	Approved	None posted
Oct 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90865
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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