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Generated: November 12, 2018

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Details for New Drug Application (NDA): 200043

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NDA 200043 describes ARMODAFINIL, which is a drug marketed by Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc, and is included in five NDAs. It is available from six 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 200043
Tradename:ARMODAFINIL
Applicant:Mylan Pharms Inc
Ingredient:armodafinil
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARMODAFINIL armodafinil TABLET;ORAL 200043 ANDA Mylan Pharmaceuticals Inc. 0378-3431 0378-3431-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93)
ARMODAFINIL armodafinil TABLET;ORAL 200043 ANDA Mylan Pharmaceuticals Inc. 0378-3432 0378-3432-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 1, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 1, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 1, 2012TE:ABRLD:No

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