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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078963

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NDA 078963 describes MODAFINIL, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Appco Pharma Llc, Aurobindo Pharma Ltd, Hikma Pharms, Mylan Pharms Inc, Orchid Hlthcare, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in nine NDAs. It is available from twenty-three 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. Thirty-three suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 078963
Tradename:MODAFINIL
Applicant:Orchid Hlthcare
Ingredient:modafinil
Patents:0
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
MODAFINIL modafinil 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
MODAFINIL modafinil 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

Profile for product number 001

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

Profile for product number 002

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

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