Details for New Drug Application (NDA): 202700
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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: 202700
Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 202700
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MODAFINIL | modafinil | TABLET;ORAL | 202700 | ANDA | Alembic Pharmaceuticals Limited | 46708-385 | 46708-385-10 | 100 TABLET in 1 CARTON (46708-385-10) |
MODAFINIL | modafinil | TABLET;ORAL | 202700 | ANDA | Alembic Pharmaceuticals Limited | 46708-385 | 46708-385-30 | 30 TABLET in 1 BOTTLE (46708-385-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 18, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Oct 18, 2012 | TE: | AB | RLD: | No |
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