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Details for New Drug Application (NDA): 200156

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

The generic ingredient in ARMODAFINIL is armodafinil. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. There are twenty-one tentative approvals for this compound. Additional details are available on the armodafinil profile page.

Summary for NDA: 200156

Watson Labs Inc
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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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.