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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210954

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NDA 210954 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, Lyne, 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 210954

Tradename:	ERYTHROMYCIN
Applicant:	Amneal Pharms Co
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 210954

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 210954

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 210954

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	TABLET, DELAYED RELEASE;ORAL	210954	ANDA	Amneal Pharmaceuticals NY LLC	69238-1471	69238-1471-1	100 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1471-1)
ERYTHROMYCIN	erythromycin	TABLET, DELAYED RELEASE;ORAL	210954	ANDA	Amneal Pharmaceuticals NY LLC	69238-1471	69238-1471-3	30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1471-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	250MG
Approval Date:	Jul 2, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Jul 2, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	500MG
Approval Date:	Jul 2, 2019	TE:	AB	RLD:	No

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