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Serving leading biopharmaceutical companies globally:

Queensland Health
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090331

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NDA 090331 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-one 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 090331

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090331

Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

Suppliers and Packaging for NDA: 090331

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090331 ANDA Sandoz Inc 0781-2147 0781-2147-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2147-31)
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090331 ANDA Sandoz Inc 0781-2147 0781-2147-71 7 CAPSULE, DELAYED RELEASE in 1 CARTON (0781-2147-71)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Apr 23, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Apr 23, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Dow
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Queensland Health
Federal Trade Commission
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QuintilesIMS
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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