FDA — authorised 4 October 1993
- Application: ANDA062420
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Gentamicin in United States
FDA authorised Gentamicin on 4 October 1993
Marketing authorisations
FDA — authorised 29 April 1994
- Application: ANDA064056
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 29 April 1994
- Application: ANDA064054
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 27 June 2000
- Application: ANDA064048
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA062373
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
Gentamicin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Gentamicin approved in United States?
Yes. FDA authorised it on 4 October 1993; FDA authorised it on 29 April 1994; FDA authorised it on 29 April 1994.
Who is the marketing authorisation holder for Gentamicin in United States?
HOSPIRA holds the US marketing authorisation.