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FDA Approval

Isosulfan Blue

CompanySomerset Therapeutics, LLC (DUNS: 079947873)

Effective Date

July 23, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isosulfan blue(10 mg in 1 mL)

Registrants (1)

Somerset Therapeutics, LLC

DUNS Number

079947873

Manufacturing Establishments (1)

Labeler

Somerset Therapeutics, LLC

Registrant

Somerset Therapeutics, LLC

DUNS Number

677236695

Products (1)

Isosulfan Blue

NDC Product Code

70069-221

Application Number

ANDA210558

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

July 23, 2019

Ingredients

Isosulfan blueActive

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

POTASSIUM PHOSPHATE, MONOBASICInactive

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

SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: 22ADO53M6FClass: IACTQuantity: 6.6 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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