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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202700

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NDA 202700 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 202700

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

Pharmacology for NDA: 202700

Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

Suppliers and Packaging for NDA: 202700

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MODAFINIL	modafinil	TABLET;ORAL	202700	ANDA	Alembic Pharmaceuticals Limited	46708-385	46708-385-10	100 TABLET in 1 CARTON (46708-385-10)
MODAFINIL	modafinil	TABLET;ORAL	202700	ANDA	Alembic Pharmaceuticals Limited	46708-385	46708-385-30	30 TABLET in 1 BOTTLE (46708-385-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 18, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Oct 18, 2012	TE:	AB	RLD:	No

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