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Cerilliant
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Dow
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Federal Trade Commission
Covington

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207196

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NDA 207196 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-one suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 207196
Tradename:MODAFINIL
Applicant:Appco Pharma Llc
Ingredient:modafinil
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207196
Suppliers and Packaging for NDA: 207196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL modafinil TABLET;ORAL 207196 ANDA HERITAGE PHARMACEUTICALS INC. 23155-604 N 23155-604-01
MODAFINIL modafinil TABLET;ORAL 207196 ANDA HERITAGE PHARMACEUTICALS INC. 23155-604 N 23155-604-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 16, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 16, 2017TE:ABRLD:No

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