TheraRadar
Data updated: Jun 28, 2026

TETRACYCLINE HYDROCHLORIDE · BRECKENRIDGE

Infectious Disease Approved 1954-01-04

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

NDA
Small Molecule
18
Indications
--
Phase 3 Trials
72
Years on Market

TETRACYCLINE HYDROCHLORIDE Approval History

1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
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
230 FDA actions from 1963 to 2026
Apr 2026 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling

What TETRACYCLINE HYDROCHLORIDE Treats

22 indications

TETRACYCLINE HYDROCHLORIDE is approved for 22 conditions since its original approval in 1963. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Upper Respiratory Tract Infection
  • Lower Respiratory Tract Infection
  • Skin and Soft Tissue Infection
  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
  • Psittacosis
  • Chlamydia Trachomatis Infection
  • Relapsing Fever
  • Bartonellosis
  • Chancroid
  • Tularemia
  • Cholera
  • Brucellosis
  • Campylobacter Fetus Infection
  • Intestinal Amebiasis
  • Urinary Tract Infection
  • Acne
  • Syphilis
  • Yaws
  • Vincent's Infection
Source: FDA Label

TETRACYCLINE HYDROCHLORIDE Competitive Set

Pro

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

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 TETRACYCLINE HYDROCHLORIDE

3 of 20

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

DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
14 shared
PH HEALTH
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +11 more
MONODOX
DOXYCYCLINE
14 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverQ FeverRickettsialpox +11 more
DEMECLOCYCLINE HYDROCHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE
11 shared
EPIC PHARMA LLC
Shared indications:
Rocky Mountain Spotted FeverQ FeverRickettsialpox +8 more
🔬

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

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.

TETRACYCLINE HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infe...

Looking for the branded version?

ACHROMYCIN V

Full clinical data, patents, trials, and competitive landscape for tetracycline hydrochloride.

See ACHROMYCIN V

Data Sources

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