Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluvoxamine maleate
Product Details
NDC Product Code
63629-8018Application Number
NDA021519Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
July 7, 2021FluvoxamineActive
Code: 5LGN83G74VClass: ACTIBQuantity: 25 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT