MedPath
FDA Approval

Fenofibrate

November 1, 2019

HUMAN PRESCRIPTION DRUG LABEL

Fenofibrate(160 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Proficient Rx LP

079196022

Products (1)

Fenofibrate

63187-681

ANDA204019

ANDA (C73584)

ORAL

December 1, 2018

Code: U202363UOSClass: ACTIBQuantity: 160 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
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