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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203306


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NDA 203306 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 sixty-nine suppliers. There is one patent 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 203306
Tradename:LANSOPRAZOLE
Applicant:Natco
Ingredient:lansoprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203306
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 203306
Suppliers and Packaging for NDA: 203306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203306 ANDA Rising Pharma Holdings, Inc. 16571-742 16571-742-42 3 BOTTLE in 1 CARTON (16571-742-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203306 ANDA Bryant Ranch Prepack 71335-9694 71335-9694-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9694-1)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Jan 13, 2016TE:RLD: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 verification 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.