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Serving leading biopharmaceutical companies globally:

US Army
Argus Health
Queensland Health
Farmers Insurance
Federal Trade Commission
US Department of Justice
Johnson and Johnson

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201970

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NDA 201970 describes RASAGILINE MESYLATE, which is a drug marketed by Watson Labs Inc, Apotex Inc, Orchid Hlthcare, and Mylan Pharms Inc, and is included in four NDAs. It is available from two 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. Six suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for NDA: 201970

Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201970

Mechanism of ActionMonoamine Oxidase Inhibitors

Suppliers and Packaging for NDA: 201970

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rasagiline mesylate
TABLET;ORAL 201970 ANDA Alvogen Inc. 47781-138 47781-138-30 30 TABLET in 1 BOTTLE, PLASTIC (47781-138-30)
rasagiline mesylate
TABLET;ORAL 201970 ANDA Alvogen Inc. 47781-139 47781-139-30 30 TABLET in 1 BOTTLE, PLASTIC (47781-139-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Mar 15, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Mar 15, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Fish and Richardson
Boehringer Ingelheim

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