Mirapex Er

NDA 22421, held by Boehringer Ingelheim. Pramipexole Dihydrochloride.

As of Nov 15, 2026, NDA 22421 (Mirapex Er), held by Boehringer Ingelheim, was first approved by FDA on Feb 19, 2010, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 19, 2010
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Aug 31, 2012	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 19, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

7 strengths and forms


Mirapex Er0.375MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er0.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er1.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er3MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er4.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er2.25MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug
Mirapex Er3.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 7, 2024	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 12, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 30, 2020	Supplement 20Labeling · Standard review	Approved	Label Letter
May 10, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 28, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Jan 14, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 27, 2015	Supplement 10Labeling · Standard review	Approved	Label Letter
May 8, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 23, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 15, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 1, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 31, 2012	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 13, 2010	Supplement 1Labeling	Approved	Label Letter
Feb 19, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22421
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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