FDA — authorised 12 August 1981
- Status: approved
🇺🇸 Isoptin in United States
FDA authorised Isoptin on 12 August 1981
Marketing authorisations
FDA — authorised 12 August 1981
- Application: NDA018485
- Marketing authorisation holder: MT ADAMS
- Local brand name: ISOPTIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 1982
- Application: NDA018593
- Marketing authorisation holder: MT ADAMS
- Local brand name: ISOPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2002
- Application: NDA020943
- Marketing authorisation holder: AZURITY
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 March 2010
- Application: NDA019614
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA212965
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 20 December 2021
- Application: ANDA075136
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA215829
- Marketing authorisation holder: HERITAGE
- Status: approved
Isoptin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Isoptin approved in United States?
Yes. FDA authorised it on 12 August 1981; FDA authorised it on 12 August 1981; FDA authorised it on 8 March 1982.
Who is the marketing authorisation holder for Isoptin in United States?
Marketing authorisation holder not available in our data.