Pramipexole Dihydrochloride

ANDA 211088, held by Rising. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 211088 (Pramipexole Dihydrochloride), held by Rising, was first approved by FDA on Oct 3, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 3, 2018	Original application	Approved	None posted

Products

5 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jun 30, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jun 30, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Oct 3, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 211088
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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