Data updated: Mar 10, 2026
GENTAMICIN SULFATE
GENTAMICIN SULFATE
Approved 1980-06-05
26
Indications
--
Phase 3 Trials
45
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-06-05
- Routes
- INJECTION, TOPICAL, OPHTHALMIC
- Dosage Forms
- INJECTABLE, OINTMENT, SOLUTION/DROPS, CREAM
Companies
ABBOTT PHARMADERM BAUSCH AND LOMB PADAGIS US Fresenius Kabi ALPHARMA US PHARMS FOUGERA PHARMS INC KALAPHARM EPIC PHARMA LLC FERA PHARMS LLC Novartis WATSON LABS SOLOPAK Pfizer COSETTE Hikma PHARM SPEC PACO ENCUBE Teva SCIEGEN PHARMS SUN PHARMA CANADA EUGIA PHARMA
Active Ingredient: GENTAMICIN SULFATE
Website: ↗
GENTAMICIN SULFATE Approval History
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What GENTAMICIN SULFATE Treats
26 FDA approvalsOriginally approved for its first indication in 1980 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Jun 1980)
- • Approved indication (Jul 1980)
- • Approved indication (May 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Feb 1982)
- • Approved indication (Mar 1982)
- • Approved indication (Apr 1982)
- • Approved indication (Mar 1983)
- • Approved indication (May 1983)
- • Approved indication (Aug 1983)
- • Approved indication (Aug 1983)
- • Approved indication (Aug 1983)
- • Approved indication (Dec 1983)
- • Approved indication (Jul 1984)
- • Approved indication (Oct 1984)
- • Approved indication (Nov 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Nov 1991)
- • Approved indication (Apr 1994)
- • Approved indication (May 1994)
- • Approved indication (Aug 1995)
- • Approved indication (Jan 2004)
- • Approved indication (Jul 2004)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2024)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GENTAMICIN SULFATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.