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Details for New Drug Application (NDA): 203203

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NDA 203203 describes LANSOPRAZOLE, which is a drug marketed by Anchen Pharms, Natco Pharma Ltd, Sun Pharma Global, Krka Tovarna Zdravil, Perrigo R And D, Dexcel Pharma, Wockhardt Ltd, Ani Pharms Inc, Sandoz, Teva Pharms, Ajanta Pharma Ltd, Mylan Pharms Inc, Zydus Hlthcare, Dr Reddys Labs Ltd, Wockhardt Usa, Citron Pharma Llc, Teva Pharms Usa, and Sandoz Inc, and is included in twenty-two 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-three 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 NDA: 203203

Tradename:
LANSOPRAZOLE
Applicant:
Anchen Pharms
Ingredient:
lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary 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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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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