Details for New Drug Application (NDA): 075902
✉ Email this page to a colleague
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 075902
Tradename: | FLUVOXAMINE MALEATE |
Applicant: | Apotex |
Ingredient: | fluvoxamine maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075902
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 075902
Suppliers and Packaging for NDA: 075902
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075902 | ANDA | Apotex Corp | 60505-0164 | 60505-0164-1 | 100 TABLET in 1 BOTTLE (60505-0164-1) |
FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075902 | ANDA | Apotex Corp | 60505-0165 | 60505-0165-1 | 100 TABLET in 1 BOTTLE (60505-0165-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | May 7, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | May 7, 2001 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 7, 2001 | TE: | AB | RLD: | No |
Complete Access Available with Subscription