You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 16, 2026

Details for New Drug Application (NDA): 213628

✉ Email this page to a colleague

« Back to Dashboard

NDA 213628 describes ERYTHROMYCIN, which is a drug marketed by Barr, Carnegie, 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, Pharmobedient, 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 213628

Tradename:	ERYTHROMYCIN
Applicant:	Cadila Pharms Ltd
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 213628

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 213628

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 213628

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	TABLET;ORAL	213628	ANDA	Cadila Pharmaceuticals Limited	71209-100	71209-100-01	30 TABLET, FILM COATED in 1 BOTTLE (71209-100-01)
ERYTHROMYCIN	erythromycin	TABLET;ORAL	213628	ANDA	Cadila Pharmaceuticals Limited	71209-100	71209-100-05	100 TABLET, FILM COATED in 1 BOTTLE (71209-100-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 28, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 28, 2021	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.