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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. There are seven 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.
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: | 7 |
| 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 | 66259-037 | 66259-037-12 | 1 KIT in 1 KIT (66259-037-12) * 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 | 66259-037 | 66259-037-22 | 6 KIT in 1 CASE (66259-037-22) > 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: | RX | Dosage: | POWDER;INTRAVENOUS, INTERSTITIAL | Strength | 25MG/VIAL | ||||
| Approval Date: | Nov 21, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 21, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 1, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF CORONARY ARTERY BYPASS GRAFT IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 22, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF CARDIOVASCULAR BYPASS GRAFT AND VASCULATURE IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY | ||||||||
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