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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202566

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NDA 202566 describes MODAFINIL, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Appco Pharma Llc, Aurobindo Pharma Ltd, Hikma Pharms, Mylan Pharms Inc, Orchid Hlthcare, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in nine NDAs. It is available from twenty-three suppliers. Additional details are available on the MODAFINIL profile page.

The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 202566
Applicant:Aurobindo Pharma Ltd
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202566
Suppliers and Packaging for NDA: 202566
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL modafinil TABLET;ORAL 202566 ANDA AvPAK 50268-570 N 50268-570-12
MODAFINIL modafinil TABLET;ORAL 202566 ANDA AvPAK 50268-571 N 50268-571-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 27, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health

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