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Generated: April 18, 2019

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Details for New Drug Application (NDA): 011525

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NDA 011525 describes IC-GREEN, which is a drug marketed by Akorn and is included in one NDA. It is available from three suppliers. 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. Seven suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 011525
Tradename:IC-GREEN
Applicant:Akorn
Ingredient:indocyanine green
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011525
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 Akorn, Inc. 17478-701 17478-701-02 1 KIT in 1 CARTON (17478-701-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE * 10 mL in 1 AMPULE
IC-GREEN indocyanine green INJECTABLE;INJECTION 011525 NDA Novadaq Technologies Inc. 66259-701 66259-701-25 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (66259-701-25)

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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