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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Daiichi Sankyo
Harvard Business School
Farmers Insurance
Chubb
Mallinckrodt
Federal Trade Commission
Merck
Baxter

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090543

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NDA 090543 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-two suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 090543
Tradename:MODAFINIL
Applicant:Hikma Pharms
Ingredient:modafinil
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090543
Suppliers and Packaging for NDA: 090543
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL modafinil TABLET;ORAL 090543 ANDA West-Ward Pharmaceuticals Corp 0143-9968 N 0143-9968-30
MODAFINIL modafinil TABLET;ORAL 090543 ANDA West-Ward Pharmaceuticals Corp 0143-9968 N 0143-9968-01

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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Fuji
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