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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 063211

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NDA 063211 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 063211

Tradename:	ERYTHROMYCIN
Applicant:	Padagis Us
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 063211

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 063211

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 063211

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	GEL;TOPICAL	063211	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-966	45802-966-94	1 TUBE in 1 CARTON (45802-966-94) / 30 g in 1 TUBE
ERYTHROMYCIN	erythromycin	GEL;TOPICAL	063211	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-966	45802-966-96	1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	2%
Approval Date:	Jan 29, 1993	TE:	AT	RLD:	No

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