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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 209202

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NDA 209202 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms, Hec Pharm, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Sun Pharm, Torrent, Zydus Pharms, Perrigo R And D, Cipla, and P And L, and is included in twenty-seven NDAs. It is available from eighty-eight suppliers. 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. Ninety suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 209202
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:P And L
Ingredient:esomeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 209202 ANDA Actavis Pharma, Inc. 0591-4187 0591-4187-14 14 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-14)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 209202 ANDA Actavis Pharma, Inc. 0591-4187 0591-4187-42 42 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-42)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 5, 2019TE:RLD:No

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