Details for New Drug Application (NDA): 091476
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NDA 091476 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 091476
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Endo Operations |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 091476
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 091476
Suppliers and Packaging for NDA: 091476
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091476 | ANDA | Endo USA, Inc. | 10370-175 | 10370-175-10 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-10) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091476 | ANDA | Endo USA, Inc. | 10370-175 | 10370-175-11 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 13, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Mar 13, 2013 | TE: | AB | RLD: | No | ||||
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