MedPath
FDA Approval

LANOXIN

April 12, 2022

Human Prescription Drug Label

Digoxin(0.0625 mg in 1 1)

Products (4)

LANOXIN

59212-240

NDA020405

NDA (C73594)

ORAL

August 19, 2020

DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.0625 mg in 1 1
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

LANOXIN

59212-245

NDA020405

NDA (C73594)

ORAL

August 19, 2020

STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.1875 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C GREEN NO. 5Inactive
Code: 8J6RDU8L9XClass: IACT

LANOXIN

59212-249

NDA020405

NDA (C73594)

ORAL

August 19, 2020

DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

LANOXIN

59212-242

NDA020405

NDA (C73594)

ORAL

August 19, 2020

DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.125 mg in 1 1
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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