FDA — authorised 16 November 2023
- Application: ANDA208569
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: TERIPARATIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 EBP05 in United States
FDA authorised EBP05 on 16 November 2023
Marketing authorisations
FDA — authorised 16 November 2023
- Application: ANDA211097
- Marketing authorisation holder: APOTEX
- Local brand name: TERIPARATIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 4 June 2024
- Application: NDA218771
- Marketing authorisation holder: ALMAJECT
- Local brand name: TERIPARATIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 12 December 2025
- Application: ANDA213641
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: TERIPARATIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Other Gastroenterology approved in United States
Frequently asked questions
Is EBP05 approved in United States?
Yes. FDA authorised it on 16 November 2023; FDA authorised it on 16 November 2023; FDA authorised it on 4 June 2024.
Who is the marketing authorisation holder for EBP05 in United States?
TEVA PHARMS USA holds the US marketing authorisation.