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Generated: June 24, 2018

DrugPatentWatch Database Preview

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 Pharms Inc, Amneal Pharms Co, Lyne, Tolmar, Ivax Sub Teva Pharms, Watson Labs, G And W Labs Inc, Life Labs, Ani Pharms Inc, Dista, Naska, Parke Davis, Mylan, Abraxis Pharm, Baxter Hlthcare, Teva Parenteral, Lederle, and Purepac Pharm, and is included in sixty-two NDAs. It is available from thirty-four suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 062447
Tradename:ERYTHROMYCIN
Applicant:Perrigo Co Tennessee
Ingredient:erythromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062447
Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity
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 N 0574-4024-35
ERYTHROMYCIN erythromycin OINTMENT;OPHTHALMIC 062447 ANDA Paddock Laboratories, LLC 0574-4024 N 0574-4024-39

Profile for product number 001

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

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