Details for New Drug Application (NDA): 076715
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The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 076715
Tradename: | MODAFINIL |
Applicant: | Watson Labs Inc |
Ingredient: | modafinil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076715
Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 076715
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MODAFINIL | modafinil | TABLET;ORAL | 076715 | ANDA | Major Pharmaceuticals | 0904-6423 | 0904-6423-04 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6423-04) / 1 TABLET in 1 BLISTER PACK |
MODAFINIL | modafinil | TABLET;ORAL | 076715 | ANDA | Major Pharmaceuticals | 0904-6424 | 0904-6424-04 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6424-04) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 1, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 1, 2012 | TE: | AB | RLD: | No |
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