Pramipexole Dihydrochloride

Treats Parkinson’s disease. ANDA 203855, held by Sciegen Pharms. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 203855 (Pramipexole Dihydrochloride), held by Sciegen Pharms, was first approved by FDA on Oct 28, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2014
Supplements approved: 6
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 7 submissions below

Date	Submission	Status	Documents
Oct 28, 2014	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 7 submissions, including labeling and manufacturing supplements


May 5, 2022	Supplement 8Labeling · Standard review	Approved	None posted
May 5, 2022	Supplement 10Labeling · Standard review	Approved	None posted
May 5, 2022	Supplement 14Labeling · Standard review	Approved	None posted
May 5, 2022	Supplement 15Labeling · Standard review	Approved	None posted
May 11, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Oct 26, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 28, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203855
Drugs@FDA: Overview at FDA
Company: ScieGen 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