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New Drug Application (NDA): 018321
Company: CURIUM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNESCAN HDP TECHNETIUM TC-99M OXIDRONATE KIT N/A INJECTABLE;INJECTION Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/24/2025 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018321s025,017538s022lbl.pdf
05/22/2025 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017538s023,018321s026lbl.pdf
03/31/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf
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