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 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. Three 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. Three 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 |
| 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 VIAL in 1 VIAL (66259-146-02) / 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 VIAL in 1 VIAL (66259-146-02) / 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: | 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 a Trial | 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 a Trial | Patent Expiration: | Jul 14, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novadaq Tech | SPY AGENT GREEN KIT | indocyanine green | POWDER;INTRAVENOUS, INTERSTITIAL | 211580-001 | Nov 21, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novadaq Tech | SPY AGENT GREEN KIT | indocyanine green | POWDER;INTRAVENOUS, INTERSTITIAL | 211580-001 | Nov 21, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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