Last Updated: November 9, 2026

Details for New Drug Application (NDA): 211975

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NDA 211975 describes ERYTHROMYCIN, which is a drug marketed by Barr, Pharmobedient, Encube, Fougera Pharms, Padagis Us, Elkins Sinn, Bausch And Lomb Inc, Pharmaderm, Pharmafair, Sentiss, Paddock Llc, Alpharma Us Pharms, Bausch, Lilly, Pharmobedient Cnsltg, Renaissance Pharma, Epic Pharma Llc, Amneal Pharms Co, Torrent, Abon Pharms Llc, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Carnegie, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Rising, Ivax Sub Teva Pharms, Watson Labs, Cosette Pharms Nc, 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 seven drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.

Summary for 211975

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

Pharmacology for NDA: 211975

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 211975

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 211975

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	TABLET, DELAYED RELEASE;ORAL	211975	ANDA	Torrent Pharmaceuticals Limited	13668-586	13668-586-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-01)
ERYTHROMYCIN	erythromycin	TABLET, DELAYED RELEASE;ORAL	211975	ANDA	Torrent Pharmaceuticals Limited	13668-586	13668-586-05	500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	250MG
Approval Date:	Jul 26, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	500MG
Approval Date:	Jul 26, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Aug 13, 2024	TE:	AB	RLD:	No

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