Details for New Drug Application (NDA): 202566

NDA 202566 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 202566

Tradename:	MODAFINIL
Applicant:	Aurobindo Pharma Ltd
Ingredient:	modafinil
Patents:	0

Pharmacology for NDA: 202566

Physiological Effect

Central Nervous System Stimulation Increased Sympathetic Activity

Suppliers and Packaging for NDA: 202566

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MODAFINIL	modafinil	TABLET;ORAL	202566	ANDA	AvPAK	50268-570	50268-570-12	20 BLISTER PACK in 1 BOX (50268-570-12) / 1 TABLET in 1 BLISTER PACK (50268-570-11)
MODAFINIL	modafinil	TABLET;ORAL	202566	ANDA	AvPAK	50268-571	50268-571-12	20 BLISTER PACK in 1 BOX (50268-571-12) / 1 TABLET in 1 BLISTER PACK (50268-571-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 27, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 27, 2012	TE:	AB	RLD:	No

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