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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211580
Company: NOVADAQ TECH

Products on NDA 211580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPY AGENT GREEN KIT	INDOCYANINE GREEN	25MG/VIAL	POWDER;INTRAVENOUS, INTERSTITIAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211580s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211580Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211580Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211580Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211580Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211580Orig1s006ltr.pdf
03/16/2022	SUPPL-4	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211580Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211580Orig1s004ltr.pdf
03/13/2021	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211580s002lbl.pdf

Labels for NDA 211580

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211580Orig1s006lbl.pdf
03/16/2022	SUPPL-4	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211580Orig1s004lbl.pdf
03/13/2021	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211580s002lbl.pdf
11/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211580s000lbl.pdf

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