Pramipexole Dihydrochloride

ANDA 202353, held by Chartwell Rx. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 202353 (Pramipexole Dihydrochloride), held by Chartwell Rx, was first approved by FDA on Dec 4, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2014
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Dec 4, 2014	Original application	Approved	None posted
Dec 4, 2014	Original application	Tentative approval	None posted

Products

5 strengths and forms


Pramipexole Dihydrochloride0.375MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride0.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride1.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride3MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride4.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Feb 28, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 4, 2014	Original application	Approved	None posted
Dec 4, 2014	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 202353
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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