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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 090543

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NDA 090543 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, and Watson Labs Inc, and is included in nine NDAs. It is available from eighteen suppliers. Additional details are available on the MODAFINIL profile page.

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

Summary for 090543

Tradename:	MODAFINIL
Applicant:	Hikma Pharms
Ingredient:	modafinil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 26, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 26, 2012	TE:		RLD:	No

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