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Last Updated: December 14, 2024

Details for New Drug Application (NDA): 214920


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NDA 214920 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 Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Anda Repository, Aurobindo Pharma, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Cipla, P And L, and Dexcel, and is included in forty-five NDAs. It is available from one hundred and nine 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 eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 214920
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Prinston Inc
Ingredient:esomeprazole magnesium
Patents:0
Pharmacology for NDA: 214920
Suppliers and Packaging for NDA: 214920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 214920 ANDA Solco Healthcare US LLC 43547-001 43547-001-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 214920 ANDA Solco Healthcare US LLC 43547-001 43547-001-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Mar 28, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Mar 28, 2023TE:ABRLD:No

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