Details for New Drug Application (NDA): 075888
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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 075888
Tradename: | FLUVOXAMINE MALEATE |
Applicant: | Upsher Smith Labs |
Ingredient: | fluvoxamine maleate |
Patents: | 0 |
Pharmacology for NDA: 075888
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 075888
Suppliers and Packaging for NDA: 075888
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075888 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1670 | 0832-1670-11 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-1670-11) |
FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075888 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1671 | 0832-1671-11 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 29, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 29, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 29, 2000 | TE: | AB | RLD: | No |
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