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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 201971


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NDA 201971 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Indoco Remedies, Micro Labs, Mylan, Orchid Hlthcare, Sandoz Inc, and Watson Labs Inc, and is included in eight NDAs. It is available from six 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 201971
Tradename:RASAGILINE MESYLATE
Applicant:Mylan
Ingredient:rasagiline mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201971
Mechanism of ActionMonoamine Oxidase Inhibitors
Suppliers and Packaging for NDA: 201971
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971 ANDA Mylan Pharmaceuticals Inc. 0378-1270 0378-1270-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1270-93)
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971 ANDA Mylan Pharmaceuticals Inc. 0378-1271 0378-1271-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1271-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 15, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:May 15, 2017TE:ABRLD:No

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