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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 201892


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NDA 201892 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 201892
Tradename:RASAGILINE MESYLATE
Applicant:Chartwell Rx
Ingredient:rasagiline mesylate
Patents:0
Pharmacology for NDA: 201892
Mechanism of ActionMonoamine Oxidase Inhibitors
Suppliers and Packaging for NDA: 201892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201892 ANDA Chartwell RX, LLC 62135-676 62135-676-30 30 TABLET in 1 BOTTLE (62135-676-30)
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201892 ANDA Chartwell RX, LLC 62135-677 62135-677-30 30 TABLET in 1 BOTTLE (62135-677-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Jul 27, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jul 27, 2018TE:ABRLD:No

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