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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 062746

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NDA 062746 describes ERYTHROMYCIN, which is a drug marketed by Azurity, Barr, 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, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-six 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 062746

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

Pharmacology for NDA: 062746

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 062746

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 062746

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	CAPSULE, DELAYED REL PELLETS;ORAL	062746	ANDA	Arbor Pharmaceuticals, Inc.	24338-120	24338-120-13	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24338-120-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	250MG
Approval Date:	Dec 22, 1986	TE:	AB	RLD:	No

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