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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091269

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NDA 091269 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Krka Tovarna Zdravil, Labs Liconsa, Lannett Co Inc, 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-five 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 091269
Tradename:LANSOPRAZOLE
Applicant:Dr Reddys Labs Ltd
Ingredient:lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091269
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 091269
Suppliers and Packaging for NDA: 091269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091269 ANDA Aidarex Pharmaceuticals LLC 33261-674 N 33261-674-30
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091269 ANDA Rebel Distributors Corp 42254-331 E 42254-331-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Oct 15, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Oct 15, 2010TE:ABRLD:No

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