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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Chinese Patent Office
Colorcon
Daiichi Sankyo
UBS
Merck
Cerilliant
Chubb
Queensland Health

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200156

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NDA 200156 describes ARMODAFINIL, which is a drug marketed by Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc, 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. Thirteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
Summary for 200156
Tradename:ARMODAFINIL
Applicant:Watson Labs Inc
Ingredient:armodafinil
Patents:0
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
ARMODAFINIL armodafinil TABLET;ORAL 200156 ANDA Watson Laboratories, Inc. 0591-3703 E 0591-3703-60
ARMODAFINIL armodafinil TABLET;ORAL 200156 ANDA Watson Laboratories, Inc. 0591-3703 E 0591-3703-05

Profile for product number 002

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

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Aug 29, 2012TE:RLD:No

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Federal Trade Commission
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Julphar
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Harvard Business School
Teva
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Moodys

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