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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 063211


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NDA 063211 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, Rising, 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 063211
Tradename:ERYTHROMYCIN
Applicant:Padagis Us
Ingredient:erythromycin
Patents:0
Pharmacology for NDA: 063211
Medical Subject Heading (MeSH) Categories for 063211
Suppliers and Packaging for NDA: 063211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin GEL;TOPICAL 063211 ANDA Padagis Israel Pharmaceuticals Ltd 45802-966 45802-966-94 1 TUBE in 1 CARTON (45802-966-94) / 30 g in 1 TUBE
ERYTHROMYCIN erythromycin GEL;TOPICAL 063211 ANDA Padagis Israel Pharmaceuticals Ltd 45802-966 45802-966-96 1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jan 29, 1993TE:ATRLD:No

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