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Details for New Drug Application (NDA): 020243
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NDA 020243 describes LUVOX, which is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms, and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LUVOX profile page.
The generic ingredient in LUVOX is fluvoxamine maleate. There are eleven drug master file entries for this compound. Additional details are available on the fluvoxamine maleate profile page.
The generic ingredient in LUVOX is fluvoxamine maleate. There are eleven drug master file entries for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 020243
| Tradename: | LUVOX |
| Applicant: | Solvay |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020243
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 5, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 5, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Dec 5, 1994 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020243
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-001 | Dec 5, 1994 | Start Trial | Start Trial |
| Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-002 | Dec 5, 1994 | Start Trial | Start Trial |
| Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-004 | Dec 5, 1994 | Start Trial | Start Trial |
| Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-003 | Dec 5, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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