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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 214549

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NDA 214549 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 214549

Tradename:	ERYTHROMYCIN
Applicant:	Teva Pharms Usa Inc
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 214549

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 214549

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 214549

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	TABLET;ORAL	214549	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5571	0093-5571-01	100 TABLET, FILM COATED in 1 BOTTLE (0093-5571-01)
ERYTHROMYCIN	erythromycin	TABLET;ORAL	214549	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5571	0093-5571-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-5571-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 11, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Feb 11, 2021	TE:	AB	RLD:	No

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