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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206153

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NDA 206153 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 206153

Tradename:	RASAGILINE MESYLATE
Applicant:	Regcon Holdings
Ingredient:	rasagiline mesylate
Patents:	0

Pharmacology for NDA: 206153

Mechanism of Action	Monoamine Oxidase Inhibitors

Suppliers and Packaging for NDA: 206153

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	206153	ANDA	Avet Pharmaceuticals Inc.	23155-746	23155-746-03	30 TABLET in 1 BOTTLE (23155-746-03)
RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	206153	ANDA	Avet Pharmaceuticals Inc.	23155-747	23155-747-03	30 TABLET in 1 BOTTLE (23155-747-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Oct 4, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Oct 4, 2019	TE:	AB	RLD:	No

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