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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 208671


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NDA 208671 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, Macleods Pharms Ltd, 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-four 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 208671
Tradename:LANSOPRAZOLE
Applicant:Macleods Pharms Ltd
Ingredient:lansoprazole
Patents:0
Pharmacology for NDA: 208671
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 208671
Suppliers and Packaging for NDA: 208671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 208671 ANDA Macleods Pharmaceuticals Limited 33342-310 33342-310-07 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07)
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 208671 ANDA Macleods Pharmaceuticals Limited 33342-311 33342-311-07 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-311-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Nov 4, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Nov 4, 2024TE:ABRLD:No

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