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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207167


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NDA 207167 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Breckenridge, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt, Xiromed, Zydus Hlthcare, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising, and is included in thirty-three NDAs. It is available from seventy 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 207167
Tradename:LANSOPRAZOLE
Applicant:Aurobindo Pharma Ltd
Ingredient:lansoprazole
Patents:0
Pharmacology for NDA: 207167
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 207167
Suppliers and Packaging for NDA: 207167
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 207167 ANDA Aurobindo Pharma Limited 65862-895 65862-895-78 10 BLISTER PACK in 1 CARTON (65862-895-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (65862-895-10)
LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 207167 ANDA Aurobindo Pharma Limited 65862-896 65862-896-78 10 BLISTER PACK in 1 CARTON (65862-896-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (65862-896-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength15MG
Approval Date:Mar 28, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength30MG
Approval Date:Mar 28, 2023TE:ABRLD:No

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