What is TOPICYCLINE used for?

TOPICYCLINE is an FDA-approved medication. See full prescribing information for approved uses.

Is TOPICYCLINE FDA approved?

Yes, TOPICYCLINE is FDA approved (first approved 1977-09-21) and manufactured by Takeda.

Who makes TOPICYCLINE?

TOPICYCLINE is manufactured by Takeda.

Data updated: Mar 10, 2026

TOPICYCLINE

TETRACYCLINE HYDROCHLORIDE

Approved 1977-09-21

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Indication

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1977-09-21
Routes: TOPICAL
Dosage Forms: FOR SOLUTION

Companies

Takeda

Active Ingredient: TETRACYCLINE HYDROCHLORIDE

TOPICYCLINE Approval History

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What TOPICYCLINE Treats

1 FDA approvals

Originally approved for its first indication in 1977 .

Other (1)

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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

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.

TOPICYCLINE FDA Label Details

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Data Sources

FDA Approval: NDA050493 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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