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Details for New Drug Application (NDA): 020717
NDA 020717 describes PROVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the PROVIGIL profile page.
The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the modafinil profile page.
The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 020717
| Tradename: | PROVIGIL |
| Applicant: | Cephalon |
| Ingredient: | modafinil |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020717
| Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 020717
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROVIGIL | modafinil | TABLET;ORAL | 020717 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-925 | 43353-925-30 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30) |
| PROVIGIL | modafinil | TABLET;ORAL | 020717 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-925 | 43353-925-53 | 60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 24, 1998 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 29, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 24, 1998 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 29, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 020717
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | Start Trial | Start Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | Start Trial | Start Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | Start Trial | Start Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | Start Trial | Start Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | Start Trial | Start Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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