Details for New Drug Application (NDA): 077667
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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.
Pharmacology for NDA: 077667
Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 077667
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MODAFINIL | modafinil | TABLET;ORAL | 077667 | ANDA | Major Pharmaceuticals | 0904-6791 | 0904-6791-04 | 30 BLISTER PACK in 1 CARTON (0904-6791-04) / 1 TABLET in 1 BLISTER PACK |
MODAFINIL | modafinil | TABLET;ORAL | 077667 | ANDA | Major Pharmaceuticals | 0904-6792 | 0904-6792-04 | 30 BLISTER PACK in 1 CARTON (0904-6792-04) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 3, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Feb 3, 2014 | TE: | AB | RLD: | No |
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