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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 064187

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NDA 064187 describes ERYTHROMYCIN, which is a drug marketed by Barr, Pharmobedient, Encube, Fougera Pharms, Padagis Us, Elkins Sinn, Bausch And Lomb, Pharmaderm, Pharmafair, Sentiss, Paddock Llc, Alpharma Us Pharms, Bausch, Lilly, Pai Holdings Pharm, Pharmobedient Cnsltg, Renaissance Pharma, Epic Pharma Llc, Amneal Pharms Co, Torrent, Abon Pharms Llc, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Rising, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Ph Health, Dista, Naska, Parke Davis, Aurobindo Pharma Usa, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN 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 064187

Tradename:	ERYTHROMYCIN
Applicant:	Fougera Pharms
Ingredient:	erythromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 064187

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	2%
Approval Date:	Sep 30, 1997	TE:		RLD:	No

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