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Data updated: Jun 28, 2026

DECLOMYCIN (demeclocycline hydrochloride) · LEDERLE

Infectious Disease Approved 1960-01-14

DECLOMYCIN is FDA-approved to treat 23 conditions (same as DEMECLOCYCLINE HYDROCHLORIDE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
66
Years on Market

Details

Status
Discontinued
First Approved
1960-01-14
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, SYRUP

Companies

LEDERLE COREPHARMA
Active Ingredient: DEMECLOCYCLINE HYDROCHLORIDE

DECLOMYCIN Approval History

1961
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Original
New Indication
New Form
Label Update
371 FDA actions from 1960 to 2012 · 4 indication expansions
Sep 2012 SUPPL
Label · Labeling
FDA Letter Label
Apr 2008 SUPPL
Label · Labeling
FDA Letter Label
Dec 2003 SUPPL
Label · Labeling
FDA Letter

What DECLOMYCIN Treats

23 indications

DECLOMYCIN is approved for 23 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus Fever
  • Q Fever
  • Rickettsialpox
  • Tick Fevers
  • Mycoplasma pneumoniae Respiratory Tract Infection
  • Lymphogranuloma Venereum
  • Psittacosis
  • Trachoma
  • Inclusion Conjunctivitis
  • Nongonococcal Urethritis
  • Relapsing Fever
  • Chancroid
  • Plague
  • Tularemia
  • Cholera
  • Campylobacter fetus Infection
  • Brucellosis
  • Bartonellosis
  • Granuloma Inguinale
  • Escherichia coli Infection
  • Enterobacter aerogenes Infection
  • Haemophilus influenzae Respiratory Tract Infection

Same approved indications as DEMECLOCYCLINE HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

DECLOMYCIN FDA Label Details

Indications & Usage

FDA Label (PDF)

DECLOMYCIN is FDA-approved to treat 23 conditions — same approved indications as DEMECLOCYCLINE HYDROCHLORIDE.

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Data Sources

FDA Approval: NDA050262 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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