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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 078963

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NDA 078963 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-one suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for 078963

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

Pharmacology for NDA: 078963

Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

Suppliers and Packaging for NDA: 078963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MODAFINIL	modafinil	TABLET;ORAL	078963	ANDA	Preferred Pharmaceuticals Inc.	68788-8280	68788-8280-3	30 TABLET in 1 BOTTLE, PLASTIC (68788-8280-3)
MODAFINIL	modafinil	TABLET;ORAL	078963	ANDA	Preferred Pharmaceuticals Inc.	68788-8280	68788-8280-6	60 TABLET in 1 BOTTLE, PLASTIC (68788-8280-6)

Profile for product number 001

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

Profile for product number 002

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

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