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FDA Approval

Isosulfan Blue

Company

AuroMedics Pharma LLC (DUNS: 968961354)

Effective Date

December 5, 2019

Labeling Type

Human Prescription Drug Label

Active Ingredients

Isosulfan blue(50 mg in 5 mL)

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

AuroMedics Pharma LLC

DUNS Number

650498244

Products (1)

Isosulfan Blue

NDC Product Code

55150-240

Application Number

ANDA206831

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

December 5, 2019

Ingredients

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51Class: IACT

Isosulfan blueActive

Code: 39N9K8S2A4Class: ACTIBQuantity: 50 mg in 5 mL

SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: 94255I6E2TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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