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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 061505

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NDA 061505 describes ERYTHROMYCIN STEARATE, which is a drug marketed by Ani Pharms, Lederle, Norvium Bioscience, 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 are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.

Summary for 061505

Tradename:	ERYTHROMYCIN STEARATE
Applicant:	Norvium Bioscience
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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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