FDA — authorised 21 September 2018
- Application: ANDA210434
- Marketing authorisation holder: CIPLA LTD
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Routine deworming in United States
FDA authorised Routine deworming on 21 September 2018
Marketing authorisations
FDA — authorised 7 December 2018
- Application: ANDA210011
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2018
- Application: ANDA208979
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2019
- Application: ANDA211117
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA208094
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 2021
- Application: ANDA211034
- Marketing authorisation holder: DR REDDYS
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2024
- Application: ANDA215652
- Marketing authorisation holder: ALEMBIC
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Routine deworming approved in United States?
Yes. FDA authorised it on 21 September 2018; FDA authorised it on 7 December 2018; FDA authorised it on 14 December 2018.
Who is the marketing authorisation holder for Routine deworming in United States?
CIPLA LTD holds the US marketing authorisation.