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Indocyanine green

Indocyanine Green for Injection USP

Approved
Approval ID

c1031b17-b6e3-4153-869f-30d9c7e66bc3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 18, 2011

Manufacturers
FDA

Novadaq Technologies Inc.

DUNS: 203343858

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Indocyanine green

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75874-424
Application NumberANDA040811
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indocyanine green
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2011
FDA Product Classification

INGREDIENTS (2)

Indocyanine greenActive
Quantity: 25 mg in 1 1
Code: IX6J1063HV
Classification: ACTIB
sodium iodideInactive
Code: F5WR8N145C
Classification: IACT

Indocyanine green

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75874-820
Application NumberANDA040811
Product Classification
M
Marketing Category
C73584
G
Generic Name
Indocyanine green
Product Specifications
Effective DateNovember 18, 2011
FDA Product Classification

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Indocyanine green - FDA Drug Approval Details