Details for New Drug Application (NDA): 209966
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NDA 209966 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, and Watson Labs Inc, and is included in nine 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 suppliers are listed for this compound. 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 suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Pharmacology for NDA: 209966
| Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 209966
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MODAFINIL | modafinil | TABLET;ORAL | 209966 | ANDA | Zydus Lifesciences Limited | 70771-1051 | 70771-1051-1 | 100 TABLET in 1 BOTTLE (70771-1051-1) |
| MODAFINIL | modafinil | TABLET;ORAL | 209966 | ANDA | Zydus Lifesciences Limited | 70771-1051 | 70771-1051-3 | 30 TABLET in 1 BOTTLE (70771-1051-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 14, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 14, 2017 | TE: | AB | RLD: | No | ||||
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