FDA — authorised 5 November 1982
- Application: NDA018602
- Marketing authorisation holder: BAUSCH
- Local brand name: CARDIZEM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cardizem in United States
FDA authorised Cardizem on 5 November 1982
Marketing authorisations
FDA — authorised 24 October 1991
- Application: NDA020027
- Marketing authorisation holder: BIOVAIL LABS INTL
- Local brand name: CARDIZEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 September 1995
- Application: NDA020401
- Marketing authorisation holder: BAUSCH
- Local brand name: TIAZAC
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 January 1997
- Application: ANDA074093
- Marketing authorisation holder: CHARTWELL MOLECULES
- Indication: Labeling
- Status: approved
FDA — authorised 5 September 1997
- Application: NDA020792
- Marketing authorisation holder: BIOVAIL
- Local brand name: CARDIZEM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 June 2001
- Application: NDA020062
- Marketing authorisation holder: BAUSCH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 May 2022
- Application: ANDA215775
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 16 January 2025
- Application: ANDA208783
- Marketing authorisation holder: NOVAST LABS
- Indication: Labeling
- Status: approved
NOVAST LABS received marketing authorisation from the FDA for Cardizem on 16 January 2025. The approval was granted under the standard expedited pathway. Cardizem is a medication used for its labeling-approved indication.
FDA — authorised 24 January 2026
- Application: ANDA074752
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Indication: Labeling
- Status: approved
The FDA approved Cardizem for its approved labeling on January 24, 2026. This approval was granted to ACTAVIS LABS FL INC. The application number for this approval is ANDA074752. The approval was processed through the standard expedited pathway.
Cardizem 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 Cardizem approved in United States?
Yes. FDA authorised it on 5 November 1982; FDA authorised it on 24 October 1991; FDA authorised it on 11 September 1995.
Who is the marketing authorisation holder for Cardizem in United States?
BAUSCH holds the US marketing authorisation.