Pramipexole Dihydrochloride

ANDA 91683, held by Sun Pharm Inds Inc. Pramipexole Dihydrochloride.

As of Nov 15, 2026, ANDA 91683 (Pramipexole Dihydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Mar 27, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 27, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 27, 2013	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 2 submissions, including labeling and manufacturing supplements


May 11, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Mar 27, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91683
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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