FDA — authorised 8 July 2019
- Application: NDA211340
- Marketing authorisation holder: AZURITY
- Local brand name: KATERZIA
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 AMLODIPINE BENZOATE in United States
FDA authorised AMLODIPINE BENZOATE on 8 July 2019
Marketing authorisations
FDA — authorised 13 June 2023
- Application: ANDA215035
- Marketing authorisation holder: AMNEAL
- Local brand name: AMLODIPINE BENZOATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Status: approved
AMLODIPINE BENZOATE 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 AMLODIPINE BENZOATE approved in United States?
Yes. FDA authorised it on 8 July 2019; FDA authorised it on 13 June 2023; FDA has authorised it.
Who is the marketing authorisation holder for AMLODIPINE BENZOATE in United States?
AZURITY holds the US marketing authorisation.