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Generated: April 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050617

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NDA 050617 describes ERYGEL, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the ERYGEL profile page.

The generic ingredient in ERYGEL is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
Summary for 050617
Tradename:ERYGEL
Applicant:Mylan Pharms Inc
Ingredient:erythromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050617
Medical Subject Heading (MeSH) Categories for 050617
Suppliers and Packaging for NDA: 050617
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYGEL erythromycin GEL;TOPICAL 050617 NDA Mylan Pharmaceuticals Inc. 0378-8075 0378-8075-60 1 TUBE in 1 CARTON (0378-8075-60) > 60 g in 1 TUBE
ERYGEL erythromycin GEL;TOPICAL 050617 NDA Mylan Pharmaceuticals Inc. 0378-8075 0378-8075-93 1 TUBE in 1 CARTON (0378-8075-93) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Oct 21, 1987TE:ATRLD:Yes

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