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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 077255


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NDA 077255 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 077255
Tradename:LANSOPRAZOLE
Applicant:Teva Pharms
Ingredient:lansoprazole
Patents:0
Pharmacology for NDA: 077255
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 077255
Suppliers and Packaging for NDA: 077255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 077255 ANDA Teva Pharmaceuticals USA, Inc. 0093-7350 0093-7350-56 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-7350-56)
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 077255 ANDA Teva Pharmaceuticals USA, Inc. 0093-7351 0093-7351-56 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-7351-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Nov 10, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Nov 10, 2009TE:ABRLD:No

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