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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 040811

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NDA 040811 describes INDOCYANINE GREEN, which is a drug marketed by Diagnostic Green and is included in one NDA. It is available from three suppliers. Additional details are available on the INDOCYANINE GREEN profile page.

The generic ingredient in INDOCYANINE GREEN is indocyanine green. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 040811
Tradename:INDOCYANINE GREEN
Applicant:Diagnostic Green
Ingredient:indocyanine green
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040811
Suppliers and Packaging for NDA: 040811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811 ANDA HUB Pharmaceuticals LLC 17238-424 17238-424-02 1 KIT in 1 CARTON (17238-424-02)
INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811 ANDA Diagnostic Green GmbH 70100-424 70100-424-02 6 PACKAGE in 1 CARTON (70100-424-02) > 1 KIT in 1 PACKAGE * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/VIAL
Approval Date:Nov 21, 2007TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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