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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201950

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NDA 201950 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Carnegie, Chartwell Rx, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Regcon Holdings, Rising, Torrent, and Watson Labs Inc, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the RASAGILINE MESYLATE profile page.

The generic ingredient in RASAGILINE MESYLATE is rasagiline mesylate. There are eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for 201950

Tradename:	RASAGILINE MESYLATE
Applicant:	Apotex Inc
Ingredient:	rasagiline mesylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Sep 12, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Sep 12, 2013	TE:		RLD:	No

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