🇺🇸 TERIPARATIDE in United States

FDA authorised TERIPARATIDE on 26 November 2002 · 4,443 US adverse-event reports

Marketing authorisations

FDA — authorised 26 November 2002

  • Application: NDA021318
  • Marketing authorisation holder: LILLY
  • Status: approved

FDA — authorised 4 October 2019

  • Application: NDA211939
  • Marketing authorisation holder: ALVOGEN
  • Status: supplemented

FDA — authorised 16 November 2023

  • Application: ANDA211097
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 16 November 2023

  • Application: ANDA208569
  • Marketing authorisation holder: TEVA PHARMS USA
  • Status: supplemented

FDA — authorised 12 December 2025

  • Application: ANDA213641
  • Marketing authorisation holder: AMPHASTAR PHARMS INC
  • Status: approved

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. Nausea — 499 reports (11.23%)
  2. Fall — 497 reports (11.19%)
  3. Dizziness — 487 reports (10.96%)
  4. Back Pain — 466 reports (10.49%)
  5. Fatigue — 461 reports (10.38%)
  6. Device Malfunction — 442 reports (9.95%)
  7. Arthralgia — 423 reports (9.52%)
  8. Pain In Extremity — 414 reports (9.32%)
  9. Product Dose Omission Issue — 381 reports (8.58%)
  10. Pain — 373 reports (8.4%)

Source database →

TERIPARATIDE 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 TERIPARATIDE approved in United States?

Yes. FDA authorised it on 26 November 2002; FDA authorised it on 4 October 2019; FDA authorised it on 16 November 2023.

Who is the marketing authorisation holder for TERIPARATIDE in United States?

LILLY holds the US marketing authorisation.