Details for New Drug Application (NDA): 217917
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NDA 217917 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Bionpharma, Endo Operations, Torrent, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Norvium Bioscience, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in eighteen NDAs. It is available from eight suppliers. Additional details are available on the FLUVOXAMINE MALEATE profile page.
The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 217917
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Bionpharma |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 217917
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 217917
Suppliers and Packaging for NDA: 217917
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 217917 | ANDA | Bionpharma Inc. | 69452-287 | 69452-287-20 | 100 TABLET, FILM COATED in 1 BOTTLE (69452-287-20) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 217917 | ANDA | Bionpharma Inc. | 69452-288 | 69452-288-20 | 100 TABLET in 1 BOTTLE (69452-288-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No | ||||
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