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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 090764

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NDA 090764 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Ph Health, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, and Zydus Pharms Usa Inc, and is included in thirty NDAs. It is available from twenty-two suppliers. Additional details are available on the PRAMIPEXOLE DIHYDROCHLORIDE profile page.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 090764

Tradename:	PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:	Natco Pharma
Ingredient:	pramipexole dihydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.75MG
Approval Date:	Apr 9, 2010	TE:		RLD:	No

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