Data updated: Mar 10, 2026
TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE
Approved 1989-08-09
19
Indications
--
Phase 3 Trials
36
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1989-08-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
EPIC PHARMA LLC Baxter GLAND Hikma XGEN PHARMS XELLIA PHARMS APS WATSON LABS INC Pfizer IGI LABS INC APOTHECON Fresenius Kabi SLATE RUN PHARMA EUGIA PHARMA Viatris Teva
Active Ingredient: TOBRAMYCIN SULFATE
Website: ↗
TOBRAMYCIN SULFATE Approval History
Loading approval history...
What TOBRAMYCIN SULFATE Treats
19 FDA approvalsOriginally approved for its first indication in 1989 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (Aug 1989)
- • Approved indication (Apr 1991)
- • Approved indication (Apr 1991)
- • Approved indication (May 1991)
- • Approved indication (Jul 1991)
- • Approved indication (Nov 1991)
- • Approved indication (Jan 1992)
- • Approved indication (May 1994)
- • Approved indication (Oct 1994)
- • Approved indication (Aug 2001)
- • Approved indication (Nov 2002)
- • Approved indication (Jul 2004)Label Letter
- • Approved indication (Mar 2008)
- • Approved indication (Sep 2014)
- • Approved indication (Jul 2016)
- • Approved indication (Feb 2021)
- • Approved indication (May 2021)
- • Approved indication (Feb 2023)
- • Approved indication (Jun 2023)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
TOBRAMYCIN SULFATE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.