MedPath
FDA Approval

Fenofibrate

September 8, 2021

Human Prescription Drug Label

Fenofibrate(134 mg in 1 1)

Manufacturing Establishments (1)

APL HEALTHCARE LIMITED

Aurobindo Pharma Limited

650918514

Products (3)

Fenofibrate

59651-202

ANDA212232

ANDA (C73584)

ORAL

September 8, 2021

Code: U202363UOSClass: ACTIBQuantity: 134 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

Fenofibrate

59651-203

ANDA212232

ANDA (C73584)

ORAL

September 8, 2021

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: U202363UOSClass: ACTIBQuantity: 200 mg in 1 1
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

Fenofibrate

59651-201

ANDA212232

ANDA (C73584)

ORAL

September 8, 2021

D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
Code: U202363UOSClass: ACTIBQuantity: 67 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
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