Details for New Drug Application (NDA): 202566
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The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 202566
Tradename: | MODAFINIL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | modafinil |
Patents: | 0 |
Pharmacology for NDA: 202566
Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
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 (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 (50268-571-12) / 1 TABLET in 1 BLISTER PACK (50268-571-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No |
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