FDA — authorised 2 May 1980
- Application: ANDA062248
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: U-GENCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 GENTAMICIN SULFATE in United States
FDA authorised GENTAMICIN SULFATE on 2 May 1980 · 1,504 US adverse-event reports
Marketing authorisations
FDA — authorised 5 June 1980
- Application: ANDA062251
- Marketing authorisation holder: HIKMA
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 July 1980
- Application: ANDA062196
- Marketing authorisation holder: SANDOZ
- Local brand name: GENTAMICIN SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 23 December 1983
- Application: ANDA062477
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: GENTAMICIN SULFATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 March 1984
- Application: ANDA062480
- Marketing authorisation holder: NOVARTIS
- Local brand name: GENTACIDIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 July 1984
- Application: ANDA062531
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: GENTAMICIN SULFATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 July 1984
- Application: ANDA062501
- Marketing authorisation holder: NOVARTIS
- Local brand name: GENTACIDIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 5 October 1984
- Application: ANDA062533
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: GENTAMICIN SULFATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 6 January 1986
- Application: ANDA062588
- Marketing authorisation holder: HOSPIRA
- Local brand name: GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 February 1986
- Application: ANDA062612
- Marketing authorisation holder: HOSPIRA
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 January 1987
- Application: ANDA062635
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GENTAMICIN SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 December 1989
- Application: NDA050612
- Marketing authorisation holder: ALLERGAN
- Local brand name: PRED-G
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 21 November 1991
- Application: ANDA063149
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 November 1991
- Application: ANDA063106
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2001
- Application: ANDA064163
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GENTAK
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 July 2004
- Application: ANDA065024
- Marketing authorisation holder: FERA PHARMS LLC
- Local brand name: GENTAMICIN SULFATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 8 January 2024
- Application: ANDA215237
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 January 2024
- Application: ANDA215236
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062496
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: GENTAMICIN SULFATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA062493
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: GENTAFAIR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062932
- Marketing authorisation holder: PACO
- Local brand name: GENTAMICIN SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062507
- Marketing authorisation holder: SOLOPAK
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062530
- Marketing authorisation holder: PHARMADERM
- Local brand name: GENTAMICIN SULFATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA062471
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: GENTAMICIN SULFATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA062264
- Marketing authorisation holder: WYETH AYERST
- Local brand name: GENTAMICIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062289
- Marketing authorisation holder: KING PHARMS
- Local brand name: APOGEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062288
- Marketing authorisation holder: BRISTOL
- Local brand name: BRISTAGEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062534
- Marketing authorisation holder: PHARMADERM
- Local brand name: GENTAMICIN SULFATE
- Indication: OINTMENT — TOPICAL
- 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: 1,504
Most-reported reactions
- Drug Ineffective — 208 reports (13.83%)
- Acute Kidney Injury — 190 reports (12.63%)
- Off Label Use — 178 reports (11.84%)
- Drug Hypersensitivity — 161 reports (10.7%)
- Pyrexia — 160 reports (10.64%)
- Rash — 134 reports (8.91%)
- Nausea — 130 reports (8.64%)
- Diarrhoea — 115 reports (7.65%)
- Renal Failure Acute — 115 reports (7.65%)
- Condition Aggravated — 113 reports (7.51%)
GENTAMICIN 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 GENTAMICIN SULFATE approved in United States?
Yes. FDA authorised it on 2 May 1980; FDA authorised it on 5 June 1980; FDA authorised it on 2 July 1980.
Who is the marketing authorisation holder for GENTAMICIN SULFATE in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.