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Last Updated: September 24, 2020

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Details for New Drug Application (NDA): 062746

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NDA 062746 describes ERYTHROMYCIN, which is a drug marketed by Arbor Pharms Llc, Barr, Fougera Pharms, Perrigo Co, Teligent Pharma Inc, Elkins Sinn, Akorn, Bausch And Lomb, Perrigo Co Tennessee, Pharmaderm, Pharmafair, Paddock Llc, Alpharma Us Pharms, Lilly, Perrigo New York, Renaissance Pharma, Wockhardt Bio Ag, Mylan, Amneal Pharms Co, Torrent, Lyne, Tolmar, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms Inc, Par Pharm Inc, Dista, Naska, Parke Davis, Abraxis Pharm, Baxter Hlthcare, Teva Parenteral, Lederle, and Purepac Pharm, and is included in sixty-six NDAs. It is available from twenty-three 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 062746
Tradename:ERYTHROMYCIN
Applicant:Arbor Pharms Llc
Ingredient:erythromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062746
Medical Subject Heading (MeSH) Categories for 062746
Suppliers and Packaging for NDA: 062746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin CAPSULE, DELAYED REL PELLETS;ORAL 062746 ANDA Arbor Pharmaceuticals, Inc. 24338-120 24338-120-13 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24338-120-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Dec 22, 1986TE:ABRLD:No

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