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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216349


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NDA 216349 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, 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-four 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 216349
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Graviti Pharms
Ingredient:esomeprazole magnesium
Patents:0
Pharmacology for NDA: 216349
Suppliers and Packaging for NDA: 216349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 216349 ANDA Rising Pharma Holdings, Inc. 16571-880 16571-880-41 1 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 216349 ANDA Rising Pharma Holdings, Inc. 16571-880 16571-880-42 3 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 24, 2022TE:RLD:No

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