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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 076715


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NDA 076715 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Mylan Pharms Inc, Orbion Pharms, and Watson Labs Inc, and is included in nine NDAs. It is available from seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 076715
Tradename:MODAFINIL
Applicant:Watson Labs Inc
Ingredient:modafinil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076715
Suppliers and Packaging for NDA: 076715
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL modafinil TABLET;ORAL 076715 ANDA Major Pharmaceuticals 0904-6423 0904-6423-04 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6423-04) / 1 TABLET in 1 BLISTER PACK
MODAFINIL modafinil TABLET;ORAL 076715 ANDA Major Pharmaceuticals 0904-6424 0904-6424-04 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6424-04) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 1, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 1, 2012TE:ABRLD:No

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