TheraRadar
Data updated: May 26, 2026

SUMYCIN (tetracycline hydrochloride)

Infectious Disease Approved 1954-09-17

SUMYCIN is indicated for the treatment of Upper Respiratory Tract Infection; Lower Respiratory Tract Infection; Skin and Soft Tissue Infection; Rickettsial Infection; Rocky Mountain Spotted Fever; Typhus; Q Fever; Rickettsialpox; Psittacosis.

Source: FDA Label • STRIDES PHARMA INTL
3
Indications
--
Phase 3 Trials
71
Years on Market

Details

Status
Prescription
First Approved
1954-09-17
Routes
ORAL
Dosage Forms
TABLET, SUSPENSION, CAPSULE

SUMYCIN Approval History

1955
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Original
New Indication
New Form
Label Update
93 FDA actions from 1954 to 2025
Mar 2025 SUPPL
Label · Labeling
May 2017 SUPPL
Mfg · Manufacturing (CMC)
Sep 2004 SUPPL
Label · Labeling

What SUMYCIN Treats

9 indications

SUMYCIN is approved for 9 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Upper Respiratory Tract Infection
  • Lower Respiratory Tract Infection
  • Skin and Soft Tissue Infection
  • Rickettsial Infection
  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
Source: FDA Label

SUMYCIN Competitive Set

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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 SUMYCIN

3 of 20

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

ACHROMYCIN V
TETRACYCLINE HYDROCHLORIDE
9 shared
LEDERLE
Shared indications:
Upper Respiratory Tract InfectionLower Respiratory Tract InfectionSkin and Soft Tissue Infection +6 more
ACTICLATE
DOXYCYCLINE HYCLATE
5 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +2 more
DOXY 200
DOXYCYCLINE HYCLATE
5 shared
Fresenius Kabi
Shared indications:
Rocky Mountain Spotted FeverTyphusQ Fever +2 more
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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

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.

SUMYCIN FDA Label Details

Indications & Usage

SUMYCIN is indicated for the treatment of Upper Respiratory Tract Infection; Lower Respiratory Tract Infection; Skin and Soft Tissue Infection; Rickettsial Infection; Rocky Mountain Spotted Fever; Typhus; Q Fever; Rickettsialpox; Psittacosis.

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Data Sources

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