Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211580
Company: NOVADAQ TECH
Company: NOVADAQ TECH
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 |
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 |
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 |