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Generated: October 20, 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, Aurobindo Pharma Ltd, Heritage Pharms Inc, 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-four 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:Heritage Pharms Inc
Ingredient:modafinil
Patents:0
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 23155-604-01 100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01)
MODAFINIL modafinil TABLET;ORAL 207196 ANDA HERITAGE PHARMACEUTICALS INC. 23155-604 23155-604-03 30 TABLET in 1 BOTTLE, PLASTIC (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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