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Last Updated: March 16, 2025

Details for New Drug Application (NDA): 064030

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NDA 064030 describes ERYTHROMYCIN, which is a drug marketed by Barr, Carnegie, 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, Norvium Bioscience, Amneal Pharms Co, Torrent, 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, Endo Operations, Dista, Naska, Parke Davis, Aurobindo Pharma Usa, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland Pharma Ltd, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-seven 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 064030

Tradename:	ERYTHROMYCIN
Applicant:	Sentiss
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 064030

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 064030

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 064030

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	OINTMENT;OPHTHALMIC	064030	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-670	60760-670-35	1 TUBE in 1 CARTON (60760-670-35) / 3.5 g in 1 TUBE
ERYTHROMYCIN	erythromycin	OINTMENT;OPHTHALMIC	064030	ANDA	Proficient Rx LP	63187-267	63187-267-35	1 TUBE in 1 CARTON (63187-267-35) / 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	0.5%
Approval Date:	Jul 18, 1996	TE:	AT	RLD:	No

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