Pramipexole Dihydrochloride

Treats Parkinson's disease. ANDA 90781, held by Glenmark Pharms Ltd. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 90781 (Pramipexole Dihydrochloride), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 8, 2010, with 8 approved supplements and 0 published complete response letters.

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

What It's For

From the FDA-approved label (Indications and Usage)

Pramipexole dihydrochloride tablets are 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 9 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 Dihydrochloride1MG · tablet;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride1.5MG · tablet;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride0.75MG · tablet;oral	Pramipexole Dihydrochloride	Rx

All 9 submissions, including labeling and manufacturing supplements


May 10, 2023	Supplement 9Labeling · Standard review	Approved	None posted
May 10, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 8Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 11, 2015	Supplement 2Manufacturing	Approved	None posted
Oct 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90781
Drugs@FDA: Overview at FDA
Company: Glenmark 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