Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202158
Company: NORTHSTAR MEDICAL
Company: NORTHSTAR MEDICAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RADIOGENIX SYSTEM | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 30-1153mCi/GENERATOR | SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/08/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/202158Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202158s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202158Orig1s017ltr.pdf | |
12/28/2020 | SUPPL-15 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202158s015lbl.pdf | ||
07/29/2019 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202158s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202158Orig1s009ltr.pdf | |
05/22/2018 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s003ltr.pdf | |
03/09/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/19/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202158s017lbl.pdf | |
12/28/2020 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202158s015lbl.pdf | |
07/29/2019 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202158s009lbl.pdf | |
07/29/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202158s009lbl.pdf | |
05/22/2018 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s003lbl.pdf | |
03/09/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s002lbl.pdf | |
02/08/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s000lbl.pdf |