Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Daiichi Sankyo
Farmers Insurance
Federal Trade Commission

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201970

« Back to Dashboard

NDA 201970 describes RASAGILINE MESYLATE, which is a drug marketed by Alkem Labs Ltd, Apotex Inc, Mylan Pharms Inc, Orchid Hlthcare, and Watson Labs Inc, and is included in five NDAs. It is available from four 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 201970
Applicant:Orchid Hlthcare
Ingredient:rasagiline mesylate
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 rasagiline mesylate TABLET;ORAL 201970 ANDA Alvogen, Inc. 47781-138 N 47781-138-30
RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201970 ANDA Alvogen, Inc. 47781-139 N 47781-139-30

Profile for product number 001

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

Profile for product number 002

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.