Pramipexole Dihydrochloride

ANDA 203615, held by Actavis Elizabeth. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 203615 (Pramipexole Dihydrochloride), held by Actavis Elizabeth, was first approved by FDA on Jan 3, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 3, 2017
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Jan 3, 2017	Original application	Approved	None posted
Oct 14, 2016	Original application	Approved	None posted

Products

2 strengths and forms


Pramipexole Dihydrochloride2.25MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride3.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


May 31, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Jan 3, 2017	Original application	Approved	None posted
Oct 14, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 203615
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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