Pramipexole Dihydrochloride

ANDA 78551, held by Heritage Pharma Avet. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 78551 (Pramipexole Dihydrochloride), held by Heritage Pharma Avet, was first approved by FDA on Oct 8, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2010
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 8, 2010	Original application	Approved	None posted

Products

5 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 Dihydrochloride1MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1.5MG · tablet;oral	Pramipexole Dihydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 10, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Mar 10, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Mar 10, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Oct 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78551
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