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FDA Approval

Isosulfan Blue

CompanyMylan Institutional LLC (DUNS: 790384502)

Effective Date

September 16, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isosulfan blue(10 mg in 1 mL)

Products (1)

Isosulfan Blue

NDC Product Code

67457-220

Application Number

ANDA090874

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

July 19, 2017

Ingredients

Isosulfan blueActive

Code: 39N9K8S2A4Class: ACTIBQuantity: 10 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RNClass: IACTQuantity: 6.6 mg in 1 mL

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51Class: IACTQuantity: 2.7 mg in 1 mL

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