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Data updated: Mar 10, 2026

DOXYCYCLINE

DOXYCYCLINE
Infectious Disease Approved 1983-10-27
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
32
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Prescription
First Approved
1983-10-27
Routes
ORAL, INJECTION
Dosage Forms
FOR SUSPENSION, CAPSULE, TABLET, INJECTABLE

Companies

Lupin STRIDES PHARMA INTL STRIDES PHARMA Dr. Reddy's IMPAX LABS INC WATSON LABS Sun Pharma CHARTWELL RX ALEMBIC ZYDUS PHARMS CHARTWELL HERITAGE AMNEAL PHARMS AIPING PHARM INC Hikma Novartis Viatris COSETTE RISING MACLEODS PHARMS LTD PRINSTON INC Apotex LANNETT CO INC
Active Ingredient: DOXYCYCLINE

DOXYCYCLINE Approval History

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What DOXYCYCLINE Treats

9 indications

DOXYCYCLINE is approved for 9 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
  • Respiratory Tract Infection
  • Lymphogranuloma Venereum
  • Psittacosis
  • Trachoma
Source: FDA Label

Drugs Similar to DOXYCYCLINE

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

ACTICLATE
DOXYCYCLINE HYCLATE
9 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +6 more
DOXY 200
DOXYCYCLINE HYCLATE
9 shared
Fresenius Kabi
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +6 more
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
9 shared
PRINSTON INC
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +6 more
MONODOX
DOXYCYCLINE
9 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +6 more
ACHROMYCIN V
TETRACYCLINE HYDROCHLORIDE
5 shared
AVET
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +2 more
DOXY 100
DOXYCYCLINE HYCLATE
5 shared
Fresenius Kabi
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +2 more
SUMYCIN
TETRACYCLINE HYDROCHLORIDE
5 shared
STRIDES PHARMA INTL
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +2 more
AMPICILLIN SODIUM
AMPICILLIN SODIUM
1 shared
SAGENT PHARMS INC
Shared indications:
Respiratory Tract Infection
ARIKAYCE KIT
AMIKACIN SULFATE
1 shared
INSMED INC
Shared indications:
Respiratory Tract Infection
CEPHALEXIN
CEPHALEXIN
1 shared
Teva
Shared indications:
Respiratory Tract Infection
CLEOCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE
1 shared
Pfizer
Shared indications:
Respiratory Tract Infection
CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE
1 shared
GLENMARK PHARMS LTD
Shared indications:
Respiratory Tract Infection
CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE
1 shared
RISING
Shared indications:
Respiratory Tract Infection
ERY-TAB
ERYTHROMYCIN
1 shared
PHARMOBEDIENT
Shared indications:
Respiratory Tract Infection
PULMOZYME
DORNASE ALFA
1 shared
Roche
Shared indications:
Respiratory Tract Infection
SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM
1 shared
PADAGIS US
Shared indications:
Trachoma
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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

DOXYCYCLINE FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent 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. Doxycycline is indicated for the treatment of the following infections: R...

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Data Sources

FDA Approval: ANDA201678 → Label: DailyMed → Trials: ClinicalTrials.gov →

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