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 useInitial U.S. Approval: 1994
Approved
Approval ID
9156a6f7-4692-4d97-9118-dad2a688e6f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
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 Code63629-8018
Application NumberNDA021519
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fluvoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2021
FDA Product Classification
INGREDIENTS (10)
FLUVOXAMINE MALEATEActive
Quantity: 25 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT