FDA — authorised 28 December 1989
- Application: NDA019456
- Marketing authorisation holder: LEO PHARM
- Local brand name: PINDAC
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised PINACIDIL on 28 December 1989
Yes. FDA authorised it on 28 December 1989; FDA has authorised it.
LEO PHARM holds the US marketing authorisation.