FDA — authorised 15 March 1966
- Application: ANDA060462
- Marketing authorisation holder: SCHERING
- Local brand name: GARAMYCIN
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Garamycin in United States
FDA authorised Garamycin on 15 March 1966
Marketing authorisations
FDA — authorised 15 March 1966
- Application: ANDA060463
- Marketing authorisation holder: SCHERING
- Local brand name: GARAMYCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 19 June 1970
- Marketing authorisation holder: SCHERING
- Status: approved
FDA — authorised 19 June 1970
- Application: NDA050039
- Marketing authorisation holder: SCHERING
- Local brand name: GARAMYCIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 November 1970
- Application: NDA050425
- Marketing authorisation holder: SCHERING
- Local brand name: GARAMYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 3 March 1981
- Application: ANDA061716
- Marketing authorisation holder: SCHERING
- Local brand name: GARAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 October 1993
- Application: ANDA062420
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
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
Garamycin 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 Garamycin approved in United States?
Yes. FDA authorised it on 15 March 1966; FDA authorised it on 15 March 1966; FDA authorised it on 19 June 1970.
Who is the marketing authorisation holder for Garamycin in United States?
SCHERING holds the US marketing authorisation.