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FDA Approval

LYMPHAZURIN

CompanyUNITED STATES SURGICAL CORPORATION (DUNS: 044680650)

Effective Date

January 31, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isosulfan blue(10 mg in 1 mL)

Manufacturing Establishments (2)

BEN VENUE LABORATORIES, INC.

Labeler

UNITED STATES SURGICAL CORPORATION

DUNS Number

004327953

SIGMA-ALDRICH CO LTD

Labeler

UNITED STATES SURGICAL CORPORATION

DUNS Number

397924143

Products (1)

LYMPHAZURIN

NDC Product Code

63261-250

Application Number

NDA018310

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

December 23, 2011

Ingredients

Isosulfan blueActive

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

SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: 22ADO53M6FClass: IACT

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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