FDA — authorised 27 November 1985
- Application: NDA019478
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: ADALAT
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Anti-hypertensive therapy on 27 November 1985
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 27 November 1985; FDA has authorised it.
BAYER PHARMS holds the US marketing authorisation.