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Express Scripts

Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 062447

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NDA 062447 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, 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-five 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 062447
Applicant:Perrigo Co Tennessee
Formulation / Manufacturing:see details
Pharmacology for NDA: 062447
Medical Subject Heading (MeSH) Categories for 062447
Suppliers and Packaging for NDA: 062447
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN erythromycin OINTMENT;OPHTHALMIC 062447 ANDA Paddock Laboratories, LLC 0574-4024 0574-4024-35 1 TUBE in 1 CARTON (0574-4024-35) > 3.5 g in 1 TUBE
ERYTHROMYCIN erythromycin OINTMENT;OPHTHALMIC 062447 ANDA Paddock Laboratories, LLC 0574-4024 0574-4024-39 24 TUBE in 1 CARTON (0574-4024-39) > 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.5%
Approval Date:Sep 26, 1983TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts

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