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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 062162

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NDA 062162 describes ERYTHROMYCIN ESTOLATE, which is a drug marketed by Barr, Ivax Sub Teva Pharms, Watson Labs, Alpharma Us Pharms, Cosette, 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 are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin estolate profile page.

Summary for 062162

Tradename:	ERYTHROMYCIN ESTOLATE
Applicant:	Barr
Ingredient:	erythromycin estolate
Patents:	0

Medical Subject Heading (MeSH) Categories for 062162

Anti-Bacterial Agents
Enzyme Inhibitors
Gastrointestinal Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 125MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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