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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202176

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NDA 202176 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, 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, Wockhardt Bio Ag, 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-six 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 202176

Tradename:	LANSOPRAZOLE
Applicant:	Wockhardt Bio Ag
Ingredient:	lansoprazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 202176

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	15MG
Approval Date:	Sep 14, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	30MG
Approval Date:	Sep 14, 2012	TE:	AB	RLD:	No

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