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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 200751

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NDA 200751 describes ARMODAFINIL, which is a drug marketed by Aurobindo Pharma Ltd, Corepharma, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc, and is included in six NDAs. It is available from seven 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. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

Summary for 200751

Tradename:	ARMODAFINIL
Applicant:	Lupin Ltd
Ingredient:	armodafinil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 28, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Nov 28, 2016	TE:	AB	RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Nov 28, 2016	TE:	AB	RLD:	No

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