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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 twelve drug master file entries for this compound. Eleven 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

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 0591-3703-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-3703-05)
ARMODAFINIL
armodafinil
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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