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Last Updated: January 13, 2026

Details for New Drug Application (NDA): 011525


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NDA 011525 describes IC-GREEN, which is a drug marketed by Renew Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the IC-GREEN profile page.

The generic ingredient in IC-GREEN is indocyanine green. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 011525
Tradename:IC-GREEN
Applicant:Renew Pharms
Ingredient:indocyanine green
Patents:0
Medical Subject Heading (MeSH) Categories for 011525
Coloring Agents
Suppliers and Packaging for NDA: 011525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IC-GREEN indocyanine green INJECTABLE;INJECTION 011525 NDA Renew Pharmaceuticals Limited 70100-825 70100-825-02 6 PACKAGE in 1 CARTON (70100-825-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-725-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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