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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 040811


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NDA 040811 describes INDOCYANINE GREEN, which is a drug marketed by Renew Pharms and is included in one NDA. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 040811
Tradename:INDOCYANINE GREEN
Applicant:Renew Pharms
Ingredient:indocyanine green
Patents:0
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 Renew Pharmaceuticals Limited 70100-424 70100-424-02 6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)
INDOCYANINE GREEN indocyanine green INJECTABLE;INJECTION 040811 ANDA Olympus America, Inc. 73624-424 73624-424-02 6 PACKAGE in 1 CARTON (73624-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

Profile for product number 001

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

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