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Last Updated: January 27, 2023

Details for New Drug Application (NDA): 211580


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NDA 211580 describes SPY AGENT GREEN KIT, which is a drug marketed by Novadaq Tech and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the SPY AGENT GREEN KIT profile page.

The generic ingredient in SPY AGENT GREEN KIT 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 211580
Tradename:SPY AGENT GREEN KIT
Applicant:Novadaq Tech
Ingredient:indocyanine green
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 211580
Suppliers and Packaging for NDA: 211580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580 NDA Novadaq Technologies Inc 66259-306 66259-306-13 1 KIT in 1 KIT (66259-306-13) * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01)
SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580 NDA Novadaq Technologies Inc 66259-306 66259-306-23 6 KIT in 1 CASE (66259-306-23) / 1 KIT in 1 KIT * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, INTERSTITIALStrength25MG/VIAL
Approval Date:Nov 21, 2018TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Aug 4, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:MEASURING TIME-VARYING CHANGE IN BLOOD IN A TISSUE VOLUME USING MODIFIED BEER-LAMBERT LAW IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY
Patent:See Plans and PricingPatent Expiration:Jun 4, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF VESSEL WITH ARTERIOVENOUS MALFORMATION IN VASCULAR,GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY
Patent:See Plans and PricingPatent Expiration:Apr 9, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION IN SURGICAL FLAPS IN VASCULAR,GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

Expired US Patents for NDA 211580

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 See Plans and Pricing See Plans and Pricing
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 See Plans and Pricing See Plans and Pricing
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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