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FDA Approval

Digoxin

CompanyA-S Medication Solutions (DUNS: 830016429)

Effective Date

July 25, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Digoxin(125 ug in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

Labeler

A-S Medication Solutions

DUNS Number

830016429

Products (1)

Digoxin

NDC Product Code

50090-4432

Application Number

ANDA077002

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 3, 2018

Ingredients

Code: 73K4184T59Class: ACTIBQuantity: 125 ug in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: 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

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