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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209966

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NDA 209966 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 209966

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

Pharmacology for NDA: 209966

Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

Suppliers and Packaging for NDA: 209966

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MODAFINIL	modafinil	TABLET;ORAL	209966	ANDA	Zydus Lifesciences Limited	70771-1051	70771-1051-1	100 TABLET in 1 BOTTLE (70771-1051-1)
MODAFINIL	modafinil	TABLET;ORAL	209966	ANDA	Zydus Lifesciences Limited	70771-1051	70771-1051-3	30 TABLET in 1 BOTTLE (70771-1051-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 14, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 14, 2017	TE:	AB	RLD:	No

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