Details for New Drug Application (NDA): 218163

NDA 218163 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Ryan Labs, Skg Pharma, and Watson Labs Inc, and is included in eleven NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for 218163

Tradename:	RASAGILINE MESYLATE
Applicant:	Skg Pharma
Ingredient:	rasagiline mesylate
Patents:	0

Pharmacology for NDA: 218163

Mechanism of Action

Monoamine Oxidase Inhibitors

Suppliers and Packaging for NDA: 218163

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	218163	ANDA	SKG Pharma Inc.	83085-007	83085-007-10	1000 TABLET in 1 BOTTLE (83085-007-10)
RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	218163	ANDA	SKG Pharma Inc.	83085-007	83085-007-30	30 TABLET in 1 BOTTLE (83085-007-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Apr 9, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Apr 9, 2024	TE:	AB	RLD:	No

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