Last Updated: October 16, 2026

Details for New Drug Application (NDA): 208343

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NDA 208343 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Lupin, Natco Pharma, Orbion Pharms, and Watson Labs Inc, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the MODAFINIL profile page.

The generic ingredient in MODAFINIL is modafinil. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for 208343

Tradename:	MODAFINIL
Applicant:	Lupin
Ingredient:	modafinil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 3, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 3, 2026	TE:	AB	RLD:	No

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