MedPath
FDA Approval

Digoxin

December 10, 2022

HUMAN PRESCRIPTION DRUG LABEL

Digoxin(125 ug in 1 1)

Products (2)

Digoxin

0904-5921

ANDA077002

ANDA (C73584)

ORAL

December 10, 2022

DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 125 ug in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Digoxin

0904-5922

ANDA077002

ANDA (C73584)

ORAL

December 10, 2022

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 250 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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