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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078730

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NDA 078730 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Kremers Urban Pharms, Labs Liconsa, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, Krka Tovarna Zdravil, Ani Pharms Inc, Dexcel Pharma, Teva Pharms Usa, Rising Pharms Inc, and Sandoz Inc, and is included in twenty-six NDAs. It is available from eighty suppliers. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 078730
Tradename:LANSOPRAZOLE
Applicant:Ani Pharms Inc
Ingredient:lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078730
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 078730
Suppliers and Packaging for NDA: 078730
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 078730 ANDA Physicians Total Care, Inc. 54868-6205 54868-6205-0 3 BLISTER PACK in 1 BOTTLE, PLASTIC (54868-6205-0) > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Oct 15, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Oct 15, 2010TE:RLD:No

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