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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 064030

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NDA 064030 describes ERYTHROMYCIN, which is a drug marketed by Arbor Pharms Llc, Barr, Fougera Pharms, Padagis Us, Teligent, Elkins Sinn, Akorn, Bausch And Lomb, Pharmaderm, Pharmafair, Paddock Llc, Alpharma Us Pharms, Lilly, Renaissance Pharma, Wockhardt Bio Ag, Mylan, Amneal Pharms Co, Torrent, Orange, Teva Pharms Usa Inc, Lyne, Tolmar, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Par Pharm Inc, Dista, Naska, Parke Davis, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy NDAs. It is available from twenty-six 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 064030
Formulation / Manufacturing:see details
Pharmacology for NDA: 064030
Medical Subject Heading (MeSH) Categories for 064030
Suppliers and Packaging for NDA: 064030
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin OINTMENT;OPHTHALMIC 064030 ANDA Henry Schein Inc. 0404-7191 0404-7191-01 1 TUBE in 1 CARTON (0404-7191-01) > 3.5 g in 1 TUBE
ERYTHROMYCIN erythromycin OINTMENT;OPHTHALMIC 064030 ANDA MWI 13985-605 13985-605-03 1 TUBE in 1 CARTON (13985-605-03) > 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.5%
Approval Date:Jul 18, 1996TE:ATRLD:No

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