Isosulfan Blue
These highlights do not include all the information needed to use ISOSULFAN BLUE INJECTION safely and effectively. See full prescribing information for ISOSULFAN BLUE INJECTION.ISOSULFAN BLUE injection, for subcutaneous use Initial U.S. Approval: 1981
Approved
Approval ID
d36ae5af-6351-497a-9151-82bcb2c62fa0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2021
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isosulfan Blue
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-805
Application NumberANDA213130
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosulfan Blue
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 3, 2021
FDA Product Classification
INGREDIENTS (4)
isosulfan blueActive
Quantity: 10 mg in 1 mL
Code: 39N9K8S2A4
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT