Details for New Drug Application (NDA): 021519
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NDA 021519 describes LUVOX, which is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms, and is included in three NDAs. It is available from five suppliers. Additional details are available on the LUVOX profile page.
The generic ingredient in LUVOX 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 LUVOX 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 021519
| Tradename: | LUVOX |
| Applicant: | Ani Pharms |
| Ingredient: | fluvoxamine maleate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021519
Suppliers and Packaging for NDA: 021519
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUVOX | fluvoxamine maleate | TABLET;ORAL | 021519 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-5988 | 50090-5988-0 | 90 TABLET, COATED in 1 BOTTLE (50090-5988-0) |
| LUVOX | fluvoxamine maleate | TABLET;ORAL | 021519 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-158 | 62559-158-01 | 100 TABLET, COATED in 1 BOTTLE (62559-158-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 20, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 20, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 20, 2007 | TE: | AB | RLD: | Yes | ||||
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