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Serving leading biopharmaceutical companies globally:

Medtronic
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Federal Trade Commission
Covington
Fuji
Citi
Queensland Health
Express Scripts
Dow
Moodys

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203187

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NDA 203187 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Kremers Urban Pharms, 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, Krka Tovarna Zdravil, 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 eighty-one 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 203187

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 203187

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203187 ANDA Sam's West, Inc. 68196-030 68196-030-03 3 BOTTLE in 1 PACKAGE (68196-030-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-030-01)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Jun 1, 2016TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
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QuintilesIMS
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US Army
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Harvard Business School
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