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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202158
Company: NORTHSTAR MEDICAL

Products on NDA 202158

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202158

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

Labels for NDA 202158

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

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