Details for New Drug Application (NDA): 075900
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NDA 075900 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, 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 nineteen NDAs. It is available from ten 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 075900
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Chartwell Rx |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 075900
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 075900
Suppliers and Packaging for NDA: 075900
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075900 | ANDA | Chartwell RX, LLC | 62135-931 | 62135-931-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-931-90) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075900 | ANDA | Chartwell RX, LLC | 62135-932 | 62135-932-60 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-932-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 23, 2006 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 23, 2006 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 23, 2006 | TE: | RLD: | No | |||||
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