Fluvoxamine Maleate
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
4239fc32-e5cb-4393-b90c-742db42b5d07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluvoxamine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2008
Application NumberANDA075902
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (9)
FLUVOXAMINE MALEATEActive
Quantity: 100 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT