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Generated: April 28, 2017

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Details for New Drug Application (NDA): 078963

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NDA 078963 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: 078963

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

Pharmacology for NDA: 078963

Suppliers and Packaging for NDA: 078963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078963 ANDA OrchidPharma Inc 42043-160 42043-160-01 1 BOTTLE, PLASTIC in 1 CARTON (42043-160-01) > 100 TABLET in 1 BOTTLE, PLASTIC
TABLET;ORAL 078963 ANDA OrchidPharma Inc 42043-160 42043-160-03 1 BOTTLE, PLASTIC in 1 CARTON (42043-160-03) > 30 TABLET in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 26, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 26, 2012TE:ABRLD:No

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