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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 062327


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NDA 062327 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 062327
Tradename:ERYTHROMYCIN
Applicant:Alpharma Us Pharms
Ingredient:erythromycin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 062327

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength2%
Approval Date:Apr 19, 1982TE:RLD:No

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