Pramipexole Dihydrochloride

ANDA 91254, held by Heritage Pharma Avet. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 91254 (Pramipexole Dihydrochloride), held by Heritage Pharma Avet, was first approved by FDA on Nov 30, 2010, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2010
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 30, 2010	Original application	Approved	None posted

Products

6 strengths and forms


Pramipexole Dihydrochloride0.125MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.25MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.5MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.75MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1.5MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Jul 2, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Jul 2, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Jul 2, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Dec 20, 2011	Supplement 2Labeling	Approved	None posted
Nov 30, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91254
Drugs@FDA: Overview at FDA
Company: Heritage Pharma Avet

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