FDA — authorised 12 December 1980
- Application: NDA050541
- Marketing authorisation holder: NOVARTIS
- Local brand name: TOBREX
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Tobi in United States
FDA authorised Tobi on 12 December 1980
Marketing authorisations
FDA — authorised 25 November 1981
- Application: NDA050555
- Marketing authorisation holder: NOVARTIS
- Local brand name: TOBREX
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 13 December 1984
- Application: ANDA062535
- Marketing authorisation holder: SANDOZ
- Local brand name: TOBREX
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 May 2000
- Application: ANDA064052
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 September 2001
- Application: ANDA065026
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 February 2002
- Application: ANDA065087
- Marketing authorisation holder: APOTEX INC
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 July 2004
- Application: NDA050789
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 10 October 2013
- Application: ANDA091589
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 July 2015
- Application: ANDA205501
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 March 2017
- Application: ANDA208964
- Marketing authorisation holder: LUPIN
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 28 June 2017
- Application: ANDA207444
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 July 2018
- Application: ANDA207080
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 26 December 2019
- Application: ANDA207136
- Marketing authorisation holder: SUN PHARM
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 1 April 2021
- Application: ANDA212848
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 7 July 2021
- Application: ANDA211847
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 16 August 2022
- Application: NDA050818
- Marketing authorisation holder: HARROW EYE
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2023
- Application: ANDA214478
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 27 July 2023
- Application: ANDA217344
- Marketing authorisation holder: MICRO LABS
- Local brand name: TOBRAMYCIN
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 10 December 2025
- Application: ANDA217597
- Marketing authorisation holder: ALEMBIC
- Status: approved
Tobi 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 Tobi approved in United States?
Yes. FDA authorised it on 12 December 1980; FDA authorised it on 25 November 1981; FDA authorised it on 13 December 1984.
Who is the marketing authorisation holder for Tobi in United States?
NOVARTIS holds the US marketing authorisation.