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Generated: January 16, 2019

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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. 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. Seven 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:0
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 66259-036 66259-036-11 1 KIT in 1 KIT (66259-036-11) * 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 66259-036 66259-036-21 6 KIT in 1 CASE (66259-036-21) > 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
Regulatory Exclusivity Expiration:Nov 21, 2021
Regulatory Exclusivity Use:NEW PRODUCT

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