What is ERYTHROMYCIN ESTOLATE used for?

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

Is ERYTHROMYCIN ESTOLATE FDA approved?

Yes, ERYTHROMYCIN ESTOLATE is FDA approved (first approved 1979-06-14) and manufactured by WATSON LABS.

Who makes ERYTHROMYCIN ESTOLATE?

ERYTHROMYCIN ESTOLATE is manufactured by WATSON LABS.

Data updated: Mar 10, 2026

ERYTHROMYCIN ESTOLATE

Approved 1979-06-14

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1979-06-14
Routes: ORAL
Dosage Forms: CAPSULE, SUSPENSION

Companies

WATSON LABS IVAX SUB TEVA PHARMS COSETTE ALPHARMA US PHARMS Teva LIFE LABS

Active Ingredient: ERYTHROMYCIN ESTOLATE

ERYTHROMYCIN ESTOLATE Approval History

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What ERYTHROMYCIN ESTOLATE Treats

6 FDA approvals

Originally approved for its first indication in 1979 . Covers 6 distinct patient populations.

Other (6)

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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.

ERYTHROMYCIN ESTOLATE FDA Label Details

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Data Sources

FDA Approval: ANDA062087 → Trials: ClinicalTrials.gov →

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