Home Applications 211580 Application 211580
Type NDA
Sponsor NOVADAQ TECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPY AGENT GREEN KIT INDOCYANINE GREEN POWDER;INTRAVENOUS, INTERSTITIAL 25MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211580-001 SPY AGENT GREEN KIT INDOCYANINE GREEN 25MG/VIAL POWDER / INTRAVENOUS, INTERSTITIAL RLD, RS 2018-11-21
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211580-001 8185176 2028-06-04 U-2462 2018-12-20 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 N211580-001 11712320 2039-07-14 Drug product 2023-08-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211580-001 I-911 2026-06-05
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N211580-001 SPY AGENT GREEN KIT 25MG/VIAL POWDER / INTRAVENOUS, INTERSTITIAL RLD, RS 2018-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211580-001 SPY AGENT GREEN KIT 25MG/VIAL POWDER / INTRAVENOUS, INTERSTITIAL RLD, RS 2018-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211580-001 SPY AGENT GREEN KIT 25MG/VIAL POWDER / INTRAVENOUS, INTERSTITIAL RLD, RS 2018-11-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211580-001 SPY AGENT GREEN KIT 25MG/VIAL POWDER / INTRAVENOUS, INTERSTITIAL RLD, RS 2018-11-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 341 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 9421280 2025-11-24 U-2466 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 9421280 2025-11-24 U-2467 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211580-001 9421280 2025-11-24 U-2466 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 9421280 2025-11-24 U-2467 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 8185176 2028-06-04 U-2462 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 8647605 2029-02-11 U-2468 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 8647605 2029-02-11 U-2464 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 8406860 2029-04-09 U-2463 2018-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 10631746 2035-08-04 U-2815 Drug product 2020-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211580-001 11712320 2039-07-14 Drug product 2023-08-31 6a471c1ec25d…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66259-036 PINPOINT Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-036 PINPOINT Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-036 PINPOINT Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-037 PINPOINT Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-306 SPY Elite Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-903 SPY-PHI Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-903 SPY-PHI Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-903 SPY-PHI Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-903 SPY-PHI Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-903 SPY-PHI Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-936 SPY-MIS Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-936 SPY-MIS Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-936 SPY-MIS Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-936 SPY-MIS Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-936 SPY-MIS Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-937 SPY Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-937 SPY Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current 66259-937 SPY Lymphatics Kit indocyanine green Novadaq Technologies Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74446 SUPPL 2023-06-06 74445 SUPPL 2023-06-06 74441 SUPPL 2023-06-06 70792 SUPPL 2022-04-19 70764 SUPPL 2022-04-14 70096 SUPPL 2022-02-04 57126 ORIG 2019-01-07 56718 ORIG 2018-12-12 56552 ORIG 2018-11-23 63065 ORIG 1900-01-01