Last Updated: June 17, 2026

Details for New Drug Application (NDA): 202366


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NDA 202366 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Novitium Pharma, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Xiromed, Zydus Hlthcare, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising, and is included in thirty-four NDAs. It is available from sixty-four suppliers. There are two patents protecting this drug. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 202366
Tradename:LANSOPRAZOLE
Applicant:Zydus Hlthcare
Ingredient:lansoprazole
Patents:0
Pharmacology for NDA: 202366
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 202366
Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Aug 19, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Aug 19, 2013TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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