Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202158
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 Prescription 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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202158s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202158Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
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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