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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 202566


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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
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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 27, 2012TE:ABRLD:No

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