Details for New Drug Application (NDA): 020717
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NDA 020717 describes PROVIGIL, which is a drug marketed by Nuvo Pharms and is included in one NDA. It is available from five suppliers. 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-one 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-one suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 020717
| Tradename: | PROVIGIL |
| Applicant: | Nuvo Pharms |
| Ingredient: | modafinil |
| Patents: | 0 |
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 | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 24, 1998 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020717
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | 4,927,855*PED | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | 4,177,290 | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | 5,618,845 | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | 7,297,346*PED | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | 4,177,290 | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | 7,297,346*PED | ⤷ Get Started Free |
| Nuvo Pharms | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | RE37516*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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