FDA — authorised 20 December 1990
- Marketing authorisation holder: SMITHKLINE BEECHAM
- Status: approved
🇺🇸 Dynacirc in United States
FDA authorised Dynacirc on 20 December 1990
Marketing authorisations
FDA — authorised 20 December 1990
- Application: NDA019546
- Marketing authorisation holder: SMITHKLINE BEECHAM
- Local brand name: DYNACIRC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 January 2006
- Application: ANDA077317
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: ISRADIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 2006
- Application: ANDA077169
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: ISRADIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 November 2015
- Application: ANDA201067
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ISRADIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Dynacirc 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 Dynacirc approved in United States?
Yes. FDA authorised it on 20 December 1990; FDA authorised it on 20 December 1990; FDA authorised it on 5 January 2006.
Who is the marketing authorisation holder for Dynacirc in United States?
SMITHKLINE BEECHAM holds the US marketing authorisation.