Pramipexole Dihydrochloride

ANDA 202206, held by Ph Health. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 202206 (Pramipexole Dihydrochloride), held by Ph Health, was first approved by FDA on Feb 6, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 6, 2014
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 6, 2014	Original application	Approved	None posted

Products

7 strengths and forms


Pramipexole Dihydrochloride0.375MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride0.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride1.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride2.25MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride3MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride3.75MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued
Pramipexole Dihydrochloride4.5MG · tablet, extended release;oral	Pramipexole Dihydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Oct 19, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Mar 28, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Mar 28, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Mar 28, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Feb 6, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202206
Drugs@FDA: Overview at FDA
Company: PH Health

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