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FDA Approval

Isosulfan Blue

CompanyMeitheal Pharmaceuticals Inc. (DUNS: 080548348)

Effective Date

October 12, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isosulfan blue(10 mg in 1 mL)

Manufacturing Establishments (1)

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Labeler

Meitheal Pharmaceuticals Inc.

DUNS Number

421297554

Products (1)

Isosulfan Blue

NDC Product Code

71288-805

Application Number

ANDA213130

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

November 3, 2021

Ingredients

Isosulfan blueActive

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

waterInactive

Code: 059QF0KO0RClass: IACT

sodium phosphate, dibasic, anhydrousInactive

Code: 22ADO53M6FClass: IACT

potassium phosphate, monobasicInactive

Code: 4J9FJ0HL51Class: IACT

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