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. There are six 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. Two 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:	6

Medical Subject Heading (MeSH) Categories for 211580

Coloring Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS, INTERSTITIAL			Strength	25MG/VIAL
Approval Date:	Nov 21, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 5, 2026
Regulatory Exclusivity Use:	FOR FLUORESCENCE IMAGING OF LYMPH NODES AND DELINEATION OF LYMPHATIC VESSELS DURINGLYMPHATIC MAPPING IN ADULTS WITH BREAST CANCER FOR WHICH THIS PROCEDURE IS A COMPONENT OF INTRAOPERATIVEMANAGEMENT
Patent:	⤷ Try for Free	Patent Expiration:	Aug 4, 2035	Product Flag?	Y	Substance 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:	⤷ Try for Free	Patent Expiration:	Jul 14, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 211580

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

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