Pramipexole Dihydrochloride

ANDA 90151, held by Pharmobedient. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 90151 (Pramipexole Dihydrochloride), held by Pharmobedient, was first approved by FDA on Apr 30, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 30, 2012	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 Dihydrochloride1MG · tablet;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride1.5MG · tablet;oral	Pramipexole Dihydrochloride	Rx
Pramipexole Dihydrochloride0.75MG · tablet;oral	Pramipexole Dihydrochloride	Rx

All 7 submissions, including labeling and manufacturing supplements


Nov 15, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Apr 28, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 15, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Aug 15, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Apr 30, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90151
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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