FDA — authorised 1 November 1991
- Application: NDA050670
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Azithromycin for Second Community-wide MDA in United States
FDA authorised Azithromycin for Second Community-wide MDA on 1 November 1991
Marketing authorisations
FDA — authorised 28 September 1994
- Application: NDA050693
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 October 1995
- Application: NDA050710
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 July 1996
- Application: NDA050711
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Azithromycin for Second Community-wide MDA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Azithromycin for Second Community-wide MDA approved in United States?
Yes. FDA authorised it on 1 November 1991; FDA authorised it on 28 September 1994; FDA authorised it on 19 October 1995.
Who is the marketing authorisation holder for Azithromycin for Second Community-wide MDA in United States?
PFIZER holds the US marketing authorisation.