Data updated: Mar 10, 2026
TETRACYCLINE HYDROCHLORIDE
TETRACYCLINE HYDROCHLORIDE
Approved 1963-07-05
18
Indications
--
Phase 3 Trials
62
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1963-07-05
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, CAPSULE
Companies
FERRANTE ROXANE Pfizer PVT FORM PROTER ALPHARMA US PHARMS IVAX SUB TEVA PHARMS WATSON LABS CHARTWELL TETRA NOVITIUM PHARMA VALEANT PHARM INTL Sun Pharma ANI PHARMS ELKINS SINN Hikma Aurobindo Pharma HEATHER IMPAX LABS ABBOTT MAST MM WARNER CHILCOTT AMNEAL PHARMS NY SUPERPHARM BRECKENRIDGE PUREPAC PHARM
Active Ingredient: TETRACYCLINE HYDROCHLORIDE
Website: ↗
TETRACYCLINE HYDROCHLORIDE Approval History
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What TETRACYCLINE HYDROCHLORIDE Treats
18 FDA approvalsOriginally approved for its first indication in 1963 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Jul 1963)
- • Approved indication (Oct 1964)
- • Approved indication (Nov 1964)
- • Approved indication (Jul 1968)
- • Approved indication (Jul 1971)
- • Approved indication (May 1972)
- • Approved indication (Dec 1974)
- • Approved indication (Sep 1977)
- • Approved indication (Nov 1977)
- • Approved indication (May 1978)
- • Approved indication (Feb 1980)
- • Approved indication (Oct 1981)
- • Approved indication (Mar 1985)
- • Approved indication (Aug 1988)
- • Approved indication (Sep 1994)
- • Approved indication (Sep 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Mar 2020)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
TETRACYCLINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.