SUMYCIN (tetracycline hydrochloride) · STRIDES PHARMA INTL
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.
Details
- Status
- Prescription
- First Approved
- 1954-09-17
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, SUSPENSION
SUMYCIN Approval History
What SUMYCIN Treats
9 indicationsSUMYCIN 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
- Psittacosis
SUMYCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.