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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Colorcon
Cipla
Fish and Richardson
Argus Health
Express Scripts
Medtronic
Daiichi Sankyo

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203203

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NDA 203203 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Krka Tovarna Zdravil, Labs Liconsa, Lannett Co Inc, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, 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 seventy-nine suppliers. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-five 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 203203
Tradename:LANSOPRAZOLE
Applicant:Labs Liconsa
Ingredient:lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203203
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 203203
Suppliers and Packaging for NDA: 203203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203203 ANDA Xiromed LLC 70700-262 N 70700-262-30
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203203 ANDA Xiromed LLC 70700-263 N 70700-263-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Jul 25, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Jul 25, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Johnson and Johnson
Citi
Cipla
Colorcon
Daiichi Sankyo
Boehringer Ingelheim
Deloitte

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