MedPath
FDA Approval

Digoxin

August 27, 2022

Human Prescription Drug Label

Digoxin(0.250 mg in 1 1)

Manufacturing Establishments (1)

Novitium Pharma LLC

Novitium Pharma LLC

080301870

Products (3)

Digoxin

70954-202

ANDA215307

ANDA (C73584)

ORAL

August 27, 2022

DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.250 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Digoxin

70954-201

ANDA215307

ANDA (C73584)

ORAL

August 27, 2022

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.125 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT

Digoxin

70954-200

ANDA215307

ANDA (C73584)

ORAL

August 27, 2022

MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.0625 mg in 1 1
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