FDA — authorised 9 August 1989
- Application: ANDA062945
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TOBRAMYCIN SULFATE in United States
FDA authorised TOBRAMYCIN SULFATE on 9 August 1989 · 222 US adverse-event reports
Marketing authorisations
FDA — authorised 31 July 1990
- Application: ANDA063081
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1991
- Application: ANDA063117
- Marketing authorisation holder: HIKMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1991
- Application: ANDA063113
- Marketing authorisation holder: HIKMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1991
- Application: ANDA063112
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1991
- Application: ANDA063111
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1991
- Application: ANDA063080
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1991
- Application: ANDA063161
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 1991
- Application: ANDA063118
- Marketing authorisation holder: HIKMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 1991
- Application: ANDA063127
- Marketing authorisation holder: HIKMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 1991
- Application: ANDA063128
- Marketing authorisation holder: HIKMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 1992
- Application: ANDA063100
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 May 1992
- Application: ANDA063116
- Marketing authorisation holder: HOSPIRA
- Local brand name: TOBRAMYCIN SULFATE (PHARMACY BULK)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 May 1994
- Application: ANDA064021
- Marketing authorisation holder: APOTHECON
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA063119
- Marketing authorisation holder: IGI LABS INC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 2001
- Application: ANDA065013
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2002
- Application: ANDA065122
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2002
- Application: ANDA065120
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: TOBRAMYCIN SULFATE (PHARMACY BULK)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 2004
- Application: NDA050789
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 March 2008
- Application: ANDA065407
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 2014
- Application: ANDA205685
- Marketing authorisation holder: XELLIA PHARMS APS
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 2014
- Application: ANDA205179
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 2016
- Application: ANDA206965
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 February 2021
- Application: ANDA209346
- Marketing authorisation holder: GLAND
- Local brand name: TOBRAMYCIN SULFATE (PHARMACY BULK)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA209621
- Marketing authorisation holder: GLAND
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 May 2021
- Application: ANDA211189
- Marketing authorisation holder: GLAND
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 February 2023
- Application: ANDA217029
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 2023
- Application: ANDA217519
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA063122
- Marketing authorisation holder: IGI LABS INC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA063121
- Marketing authorisation holder: IGI LABS INC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA064026
- Marketing authorisation holder: APOTHECON
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA063120
- Marketing authorisation holder: IGI LABS INC
- Local brand name: TOBRAMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 222
Most-reported reactions
- Infection — 36 reports (16.22%)
- Dyspnoea — 28 reports (12.61%)
- Off Label Use — 27 reports (12.16%)
- Pneumonia — 26 reports (11.71%)
- Drug Ineffective — 25 reports (11.26%)
- Infective Pulmonary Exacerbation Of Cystic Fibrosis — 18 reports (8.11%)
- Cough — 16 reports (7.21%)
- Cystic Fibrosis — 16 reports (7.21%)
- Fatigue — 15 reports (6.76%)
- Pyrexia — 15 reports (6.76%)
TOBRAMYCIN SULFATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TOBRAMYCIN SULFATE approved in United States?
Yes. FDA authorised it on 9 August 1989; FDA authorised it on 31 July 1990; FDA authorised it on 26 April 1991.
Who is the marketing authorisation holder for TOBRAMYCIN SULFATE in United States?
WATSON LABS INC holds the US marketing authorisation.