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Details for New Drug Application (NDA): 202566

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NDA 202566 describes MODAFINIL, which is a drug marketed by Alembic Ltd, Watson Labs Inc, Hikma Pharms, Orchid Hlthcare, Aurobindo Pharma Ltd, Apotex Inc, and Mylan Pharms Inc, and is included in seven 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. There are eight tentative approvals for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 202566

Tradename:
MODAFINIL
Applicant:
Aurobindo Pharma Ltd
Ingredient:
modafinil
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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