FDA — authorised 4 January 1995
- Application: ANDA073580
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: EMVERM
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
🇺🇸 Benzimidazoles in United States
FDA authorised Benzimidazoles on 4 January 1995
Marketing authorisations
FDA — authorised 21 September 2018
- Application: ANDA210434
- Marketing authorisation holder: CIPLA LTD
- Local brand name: ALBENDAZOLE
- Indication: TABLET — ORAL
- Status: approved
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 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
Other Other approved in United States
Frequently asked questions
Is Benzimidazoles approved in United States?
Yes. FDA authorised it on 4 January 1995; FDA authorised it on 21 September 2018; FDA authorised it on 7 December 2018.
Who is the marketing authorisation holder for Benzimidazoles in United States?
IMPAX LABS INC holds the US marketing authorisation.