FDA — authorised 10 December 1985
- Application: NDA020145
- Marketing authorisation holder: USPHARMA
- Local brand name: NITRO-DUR
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA authorised Nitroglycerin transdermal on 10 December 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 10 December 1985; FDA has authorised it.
USPHARMA holds the US marketing authorisation.