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Details for New Drug Application (NDA): 020243
The generic ingredient in LUVOX is fluvoxamine maleate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed 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 |
Therapeutic Class: | Antidepressants |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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 | 020243-003 | Dec 5, 1994 | ➤ Sign Up | ➤ Sign Up |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-004 | Dec 5, 1994 | ➤ Sign Up | ➤ Sign Up |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-001 | Dec 5, 1994 | ➤ Sign Up | ➤ Sign Up |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-002 | Dec 5, 1994 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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