Details for New Drug Application (NDA): 217917
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NDA 217917 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Annora Pharma, Bionpharma, Ph Health, Torrent, Aiping Pharm Inc, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Quagen, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in twenty NDAs. It is available from thirteen 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. Sixteen 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. Sixteen 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 | A-S Medication Solutions | 50090-7728 | 50090-7728-0 | 90 TABLET in 1 BOTTLE (50090-7728-0) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 217917 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4011 | 68788-4011-3 | 30 TABLET in 1 BOTTLE (68788-4011-3) |
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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