MedPath
FDA Approval

Fenofibrate

November 2, 2023

HUMAN PRESCRIPTION DRUG LABEL

Fenofibrate(130 mg in 1 1)

Products (2)

Fenofibrate

68180-131

NDA021695

NDA authorized generic (C73605)

ORAL

November 2, 2023

SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 130 mg in 1 1
D&C BLACK NO. 2Inactive
Code: 4XYU5U00C4Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SULFUR DIOXIDEInactive
Code: 0UZA3422Q4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Fenofibrate

68180-130

NDA021695

NDA authorized generic (C73605)

ORAL

November 2, 2023

GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SULFUR DIOXIDEInactive
Code: 0UZA3422Q4Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 43 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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