Details for New Drug Application (NDA): 212182
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NDA 212182 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 212182
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Bionpharma |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 212182
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 212182
Suppliers and Packaging for NDA: 212182
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 212182 | ANDA | Bionpharma Inc. | 69452-182 | 69452-182-13 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-13) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 212182 | ANDA | Bionpharma Inc. | 69452-182 | 69452-182-32 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | May 11, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 16, 2020 | TE: | AB | RLD: | No | ||||
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