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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208025

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NDA 208025 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Kremers Urban Pharms, Krka Tovarna Zdravil, Labs Liconsa, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, Ani Pharms Inc, Dexcel Pharma, Teva Pharms Usa, Rising Pharms Inc, and Sandoz Inc, and is included in twenty-six NDAs. It is available from seventy-nine suppliers. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 208025
Tradename:LANSOPRAZOLE
Applicant:Dexcel Pharma
Ingredient:lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208025
Suppliers and Packaging for NDA: 208025
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208025 NDA L. Perrigo Company 0113-0116 N 0113-0116-55
LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208025 NDA Walgreen Company 0363-1419 N 0363-1419-74

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength15MG
Approval Date:Jun 7, 2016TE:RLD:No

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