Last Updated: September 24, 2026

Details for New Drug Application (NDA): 062169

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NDA 062169 describes ERYTHROMYCIN ESTOLATE, which is a drug marketed by Barr, Ivax Sub Teva Pharms, Watson Labs, Alpharma Us Pharms, Cosette Pharms Nc, and Life Labs, and is included in seven NDAs. Additional details are available on the ERYTHROMYCIN ESTOLATE profile page.

The generic ingredient in ERYTHROMYCIN ESTOLATE is erythromycin estolate. There is one drug master file entry for this compound. Additional details are available on the erythromycin estolate profile page.

Summary for 062169

Tradename:	ERYTHROMYCIN ESTOLATE
Applicant:	Cosette Pharms Nc
Ingredient:	erythromycin estolate
Patents:	0

Medical Subject Heading (MeSH) Categories for 062169

Anti-Bacterial Agents
Enzyme Inhibitors
Gastrointestinal Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Oct 17, 1990	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Oct 17, 1990	TE:		RLD:	No

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