FDA — authorised 5 December 1967
- Application: NDA050007
- Marketing authorisation holder: PFIZER
- Local brand name: VIBRAMYCIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Vibramycin in United States
FDA authorised Vibramycin on 5 December 1967
Marketing authorisations
FDA — authorised 6 December 1967
- Application: NDA050006
- Marketing authorisation holder: PFIZER
- Local brand name: VIBRAMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 September 1972
- Application: NDA050442
- Marketing authorisation holder: PFIZER
- Local brand name: VIBRAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 1985
- Application: NDA050582
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: DORYX
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 October 1985
- Application: ANDA062653
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: DORYX
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 December 1989
- Application: NDA050641
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MONODOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 May 2005
- Application: NDA050795
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: DORYX
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Vibramycin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Vibramycin approved in United States?
Yes. FDA authorised it on 5 December 1967; FDA authorised it on 6 December 1967; FDA authorised it on 5 September 1972.
Who is the marketing authorisation holder for Vibramycin in United States?
PFIZER holds the US marketing authorisation.