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Generated: August 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207004

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NDA 207004 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Micro Labs, Mylan, Orchid Hlthcare, Sandoz Inc, and Watson Labs Inc, and is included in seven NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Summary for 207004
Tradename:RASAGILINE MESYLATE
Applicant:Micro Labs
Ingredient:rasagiline mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207004
Mechanism of ActionMonoamine Oxidase Inhibitors
Suppliers and Packaging for NDA: 207004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 207004 ANDA Micro Labs Limited 42571-220 42571-220-05 500 TABLET in 1 BOTTLE (42571-220-05)
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 207004 ANDA Micro Labs Limited 42571-220 42571-220-10 1000 TABLET in 1 BOTTLE (42571-220-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Mar 29, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Mar 29, 2019TE:ABRLD:No

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