🇺🇸 SODIUM PERTECHNETATE TC 99M in United States

FDA authorised SODIUM PERTECHNETATE TC 99M on 18 July 1974 · 73 US adverse-event reports

Marketing authorisations

FDA — authorised 18 July 1974

  • Application: NDA017471
  • Marketing authorisation holder: GE HEALTHCARE
  • Local brand name: SODIUM PERTECHNETATE TC 99M
  • Indication: SOLUTION — INJECTION, ORAL
  • Status: approved

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FDA — authorised 20 October 1976

  • Application: NDA017321
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: SODIUM PERTECHNETATE TC 99M
  • Indication: SOLUTION — INJECTION, ORAL
  • Status: approved

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FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Radioisotope Scan Abnormal — 23 reports (31.51%)
  2. Drug Ineffective — 20 reports (27.4%)
  3. Bone Scan Abnormal — 6 reports (8.22%)
  4. Product Administration Error — 6 reports (8.22%)
  5. Radiation Overdose — 5 reports (6.85%)
  6. Poor Quality Product Administered — 4 reports (5.48%)
  7. Renal Scan Abnormal — 3 reports (4.11%)
  8. Drug Interaction — 2 reports (2.74%)
  9. Drug Monitoring Procedure Not Performed — 2 reports (2.74%)
  10. Dyspnoea — 2 reports (2.74%)

Source database →

SODIUM PERTECHNETATE TC 99M in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SODIUM PERTECHNETATE TC 99M approved in United States?

Yes. FDA authorised it on 18 July 1974; FDA authorised it on 20 October 1976; FDA has authorised it.

Who is the marketing authorisation holder for SODIUM PERTECHNETATE TC 99M in United States?

GE HEALTHCARE holds the US marketing authorisation.