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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210954


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NDA 210954 describes ERYTHROMYCIN, which is a drug marketed by Arbor Pharms Llc, 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, Mylan, Amneal Pharms Co, Torrent, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus, Zydus Pharms, Lyne, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Par Pharm Inc, 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 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. Two suppliers are listed 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 210954
Medical Subject Heading (MeSH) Categories for 210954
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:RXDosage:TABLET, DELAYED RELEASE;ORALStrength250MG
Approval Date:Jul 2, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength333MG
Approval Date:Jul 2, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Jul 2, 2019TE:ABRLD:No

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