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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091509

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NDA 091509 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 091509

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

Pharmacology for NDA: 091509

Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

Suppliers and Packaging for NDA: 091509

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091509 ANDA Sun Pharma Global FZE 47335-924 47335-924-88 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-924-88)
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091509 ANDA Sun Pharma Global FZE 47335-924 47335-924-18 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-924-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Sep 13, 2013TE:ABRLD:No


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