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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202768

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NDA 202768 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. Fourteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

Summary for 202768

Tradename:	ARMODAFINIL
Applicant:	Natco Pharma Ltd
Ingredient:	armodafinil
Patents:	0

Suppliers and Packaging for NDA: 202768

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARMODAFINIL	armodafinil	TABLET;ORAL	202768	ANDA	Natco Pharma USA LLC	69339-177	69339-177-03	30 TABLET in 1 BOTTLE (69339-177-03)
ARMODAFINIL	armodafinil	TABLET;ORAL	202768	ANDA	Natco Pharma USA LLC	69339-177	69339-177-10	1000 TABLET in 1 BOTTLE (69339-177-10)

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 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 28, 2016	TE:	AB	RLD:	No

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