Details for New Drug Application (NDA): 091476
NDA 091476 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Annora Pharma, Appco, Bionpharma, Micro Labs, Ph Health, Torrent, Zydus Pharms, 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-three NDAs. It is available from sixteen suppliers. Additional details are available on the FLUVOXAMINE MALEATE profile page.
The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There is one drug master file entry for this compound. Nineteen 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 is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 091476
| Tradename: | FLUVOXAMINE MALEATE |
| Applicant: | Ph Health |
| 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 | Par Health USA, LLC | 10370-175 | 10370-175-11 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-11) |
| FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091476 | ANDA | Par Health USA, LLC | 10370-176 | 10370-176-11 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11) |
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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