MedPath
FDA Approval

Fenofibrate

September 6, 2022

HUMAN PRESCRIPTION DRUG LABEL

Fenofibrate(48 mg in 1 1)

Manufacturing Establishments (1)

Golden State Medical Supply, Inc.

Golden State Medical Supply, Inc.

603184490

Products (2)

Fenofibrate

51407-204

ANDA200884

ANDA (C73584)

ORAL

September 6, 2022

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 48 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT

Fenofibrate

51407-205

ANDA200884

ANDA (C73584)

ORAL

September 6, 2022

STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 145 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
© Copyright 2025. All Rights Reserved by MedPath