Last Updated: November 8, 2026

Details for New Drug Application (NDA): 061743

NDA 061743 describes ERYTHROMYCIN STEARATE, which is a drug marketed by Ani Pharms, Lederle, Pharmobedient, Purepac Pharm, and Watson Labs, and is included in seven NDAs. Additional details are available on the ERYTHROMYCIN STEARATE profile page.

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

Summary for 061743

Tradename:	ERYTHROMYCIN STEARATE
Applicant:	Purepac Pharm
Ingredient:	erythromycin stearate
Patents:	0

Profile for product number 001

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

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