🇺🇸 PINACIDIL in United States

FDA authorised PINACIDIL on 28 December 1989

Marketing authorisations

FDA — authorised 28 December 1989

  • Application: NDA019456
  • Marketing authorisation holder: LEO PHARM
  • Local brand name: PINDAC
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

Frequently asked questions

Is PINACIDIL approved in United States?

Yes. FDA authorised it on 28 December 1989; FDA has authorised it.

Who is the marketing authorisation holder for PINACIDIL in United States?

LEO PHARM holds the US marketing authorisation.