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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 200043

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NDA 200043 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 200043

Tradename:	ARMODAFINIL
Applicant:	Mylan Pharms Inc
Ingredient:	armodafinil
Patents:	0

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:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 1, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jun 1, 2012	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 1, 2012	TE:	AB	RLD:	No

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