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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200156

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NDA 200156 describes ARMODAFINIL, which is a drug marketed by Mylan Pharms Inc, Lupin Ltd, Watson Labs Inc, and Natco Pharma Ltd, and is included in four NDAs. It is available from four suppliers. Additional details are available on the ARMODAFINIL profile page.

The generic ingredient in ARMODAFINIL is armodafinil. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

Summary for NDA: 200156

Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200156

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 200156 ANDA Watson Laboratories, Inc. 0591-3703 0591-3703-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-3703-05)
TABLET;ORAL 200156 ANDA Watson Laboratories, Inc. 0591-3703 0591-3703-60 60 TABLET in 1 BOTTLE, PLASTIC (0591-3703-60)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Aug 29, 2012TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Aug 29, 2012TE:RLD:No
Regulatory Exclusivity Expiration:Nov 28, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

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