Mirapex Er

NDA 22514, held by Boehringer Ingelheim. Pramipexole Dihydrochloride.

As of Nov 14, 2026, NDA 22514 (Mirapex Er), held by Boehringer Ingelheim, was first approved by FDA on Mar 19, 2010, with 0 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Mar 19, 2010	Original applicationNew indication · Standard review	Approved	Review Summary Review Label Letter

Products

5 strengths and forms


Mirapex Er0.375MG · tablet, extended release; oral	Pramipexole Dihydrochloride	Rx
Mirapex Er0.75MG · tablet, extended release; oral	Pramipexole Dihydrochloride	Rx
Mirapex Er1.5MG · tablet, extended release; oral	Pramipexole Dihydrochloride	Rx
Mirapex Er3MG · tablet, extended release; oral	Pramipexole Dihydrochloride	Rx
Mirapex Er4.5MG · tablet, extended release; oral	Pramipexole Dihydrochloride	Rx

Identifiers

Application: NDA 22514
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