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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 201514

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NDA 201514 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 201514

Tradename:	ARMODAFINIL
Applicant:	Corepharma
Ingredient:	armodafinil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 25, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 25, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Mar 25, 2019	TE:		RLD:	No

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