Details for New Drug Application (NDA): 207196
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NDA 207196 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Mylan Pharms Inc, Orbion Pharms, and Watson Labs Inc, and is included in nine NDAs. It is available from seventeen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 207196
| Tradename: | MODAFINIL |
| Applicant: | Appco |
| Ingredient: | modafinil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207196
| Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 207196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MODAFINIL | modafinil | TABLET;ORAL | 207196 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604 | 23155-604-01 | 100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01) |
| MODAFINIL | modafinil | TABLET;ORAL | 207196 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604 | 23155-604-03 | 30 TABLET in 1 BOTTLE, PLASTIC (23155-604-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 16, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 16, 2017 | TE: | AB | RLD: | No | ||||
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