TheraRadar
Data updated: May 26, 2026

BACTRIM (sulfamethoxazole)

Dihydrofolate Reductase Inhibitors
Infectious Disease Approved 1973-07-30

BACTRIM is indicated for the treatment of Urinary Tract Infection; Acute Otitis Media.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
1
Priority Reviews
52
Years on Market

Details

Status
Discontinued
First Approved
1973-07-30
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, SUSPENSION, TABLET

Companies

Sun Pharma
Active Ingredient: SULFAMETHOXAZOLE , TRIMETHOPRIM

BACTRIM Approval History

1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
126 FDA actions from 1973 to 2025 · 2 indication expansions
Feb 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
May 2021 SUPPL
Label · Labeling
FDA Letter Label

What BACTRIM Treats

2 indications

BACTRIM is approved for 2 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Acute Otitis Media
Source: FDA Label

BACTRIM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONTEPO
MEITHEAL
2025 2 indic.
BLUJEPA
GSK
2025 2 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BACTRIM

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BACTRIM DS
SULFAMETHOXAZOLE
2 shared
Sun Pharma
Shared indications:
Urinary Tract InfectionAcute Otitis Media
CEFUROXIME AXETIL
CEFUROXIME AXETIL
2 shared
Lupin
Shared indications:
Acute Otitis MediaUrinary Tract Infection
SULFATRIM PEDIATRIC
SULFAMETHOXAZOLE
2 shared
PHARM ASSOC
Shared indications:
Urinary Tract InfectionAcute Otitis Media
View all 20 similar drugs Pro
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

BACTRIM FDA Label Details

Indications & Usage

FDA Label (PDF)

BACTRIM is indicated for the treatment of Urinary Tract Infection; Acute Otitis Media.

Track BACTRIM with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA018374 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.