FDA — authorised 25 July 1991
- Application: NDA019834
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: PLENDIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 PLENDIL® in United States
FDA authorised PLENDIL® on 25 July 1991
Marketing authorisation
Frequently asked questions
Is PLENDIL® approved in United States?
Yes. FDA authorised it on 25 July 1991.
Who is the marketing authorisation holder for PLENDIL® in United States?
ASTRAZENECA holds the US marketing authorisation.