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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 212949


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NDA 212949 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 212949
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Cspc Ouyi
Ingredient:esomeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212949
Suppliers and Packaging for NDA: 212949
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 212949 ANDA Mullan Pharmaceutical Inc. 83301-0006 83301-0006-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83301-0006-1)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 212949 ANDA Mullan Pharmaceutical Inc. 83301-0006 83301-0006-2 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83301-0006-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Oct 2, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Oct 2, 2020TE:ABRLD:No

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