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Serving leading biopharmaceutical companies globally:

UBS
Citi
Queensland Health
Moodys
Medtronic
Baxter
Argus Health
Deloitte
Daiichi Sankyo
Teva

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202566

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NDA 202566 describes MODAFINIL, which is a drug marketed by Alembic Pharms Ltd, Watson Labs Inc, Hikma Pharms, Orchid Hlthcare, Aurobindo Pharma Ltd, Zydus Pharms Usa Inc, Apotex Inc, Mylan Pharms Inc, and Appco Pharma Llc, and is included in nine NDAs. It is available from eighteen 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-eight suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 202566

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202566

Suppliers and Packaging for NDA: 202566

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL
modafinil
TABLET;ORAL 202566 ANDA AvPAK 50268-570 50268-570-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-570-12) > 1 TABLET in 1 BLISTER PACK (50268-570-11)
MODAFINIL
modafinil
TABLET;ORAL 202566 ANDA AvPAK 50268-571 50268-571-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-571-12) > 1 TABLET in 1 BLISTER PACK (50268-571-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 27, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
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Fish and Richardson
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Federal Trade Commission
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Argus Health

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