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Details for New Drug Application (NDA): 077667

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NDA 077667 describes MODAFINIL, which is a drug marketed by Alembic Ltd, Watson Labs Inc, Hikma Pharms, Orchid Hlthcare, Aurobindo Pharma Ltd, Apotex Inc, and Mylan Pharms Inc, and is included in seven NDAs. It is available from nineteen 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-nine suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 077667

Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077667

Suppliers and Packaging for NDA: 077667

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077667 ANDA Golden State Medical Supply, Inc. 60429-581 60429-581-01 100 TABLET in 1 BOTTLE (60429-581-01)
TABLET;ORAL 077667 ANDA Golden State Medical Supply, Inc. 60429-581 60429-581-05 500 TABLET in 1 BOTTLE (60429-581-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 3, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 3, 2014TE:ABRLD:No

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