Details for New Drug Application (NDA): 091482
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NDA 091482 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 nine 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 091482
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Actavis Elizabeth |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 091482
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 091482
Suppliers and Packaging for NDA: 091482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091482 | ANDA | Actavis Pharma, Inc. | 0228-2848 | 0228-2848-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2848-03) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091482 | ANDA | Actavis Pharma, Inc. | 0228-2849 | 0228-2849-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2849-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 23, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Nov 18, 2013 | TE: | AB | RLD: | No | ||||
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