FDA — authorised 18 August 1988
- Application: NDA050592
- Marketing authorisation holder: SANDOZ
- Status: supplemented
🇺🇸 Tobramycin and dexamethasone in United States
FDA authorised Tobramycin and dexamethasone on 18 August 1988 · 488 US adverse-event reports
Marketing authorisations
FDA — authorised 27 October 1999
- Application: ANDA064134
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: TOBRAMYCIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 July 2021
- Application: ANDA212991
- Marketing authorisation holder: AMNEAL
- Local brand name: TOBRAMYCIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 11 February 2022
- Application: ANDA212715
- Marketing authorisation holder: PADAGIS US
- Local brand name: TOBRAMYCIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 488
Most-reported reactions
- Drug Ineffective — 60 reports (12.3%)
- Ocular Hyperaemia — 58 reports (11.89%)
- Eye Pain — 56 reports (11.48%)
- Vision Blurred — 54 reports (11.07%)
- Eye Irritation — 52 reports (10.66%)
- Headache — 51 reports (10.45%)
- Off Label Use — 43 reports (8.81%)
- Rash — 40 reports (8.2%)
- Diarrhoea — 38 reports (7.79%)
- Fatigue — 36 reports (7.38%)
Other Ophthalmology approved in United States
Frequently asked questions
Is Tobramycin and dexamethasone approved in United States?
Yes. FDA authorised it on 18 August 1988; FDA authorised it on 27 October 1999; FDA authorised it on 15 July 2021.
Who is the marketing authorisation holder for Tobramycin and dexamethasone in United States?
SANDOZ holds the US marketing authorisation.