FDA.reportPublic FDA data

Application 211580

Type
NDA
Sponsor
NOVADAQ TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPY AGENT GREEN KITINDOCYANINE GREENPOWDER;INTRAVENOUS, INTERSTITIAL25MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66259-036PINPOINT Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-036PINPOINT Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-036PINPOINT Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-037PINPOINT Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-306SPY Elite Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-903SPY-PHI Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-903SPY-PHI Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-903SPY-PHI Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-903SPY-PHI Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-903SPY-PHI Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-936SPY-MIS Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-936SPY-MIS Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-936SPY-MIS Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-936SPY-MIS Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-936SPY-MIS Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-937SPY Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-937SPY Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent
66259-937SPY Lymphatics Kitindocyanine greenNovadaq Technologies IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74446SUPPL 2023-06-06
74445SUPPL 2023-06-06
74441SUPPL 2023-06-06
70792SUPPL2022-04-19
70764SUPPL2022-04-14
70096SUPPL2022-02-04
57126ORIG2019-01-07
56718ORIG2018-12-12
56552ORIG2018-11-23
63065ORIG1900-01-01