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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214278


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NDA 214278 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Pharms, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Anda Repository, Aurobindo Pharma, Marksans Pharma, Perrigo R And D, Cipla, P And L, and Dexcel, and is included in forty-two NDAs. It is available from one hundred and eight suppliers. There are two patents protecting this drug. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and ten suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 214278
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Dexcel
Ingredient:esomeprazole magnesium
Patents:2
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Oct 20, 2020TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 8, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 8, 2036Product Flag?YSubstance Flag?Delist Request?

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