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Generated: October 17, 2018

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Details for New Drug Application (NDA): 202784

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NDA 202784 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hec Pharm, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan Pharms Inc, Sun Pharm Inds Ltd, Torrent Pharms Ltd, and Perrigo R And D, and is included in thirteen NDAs. It is available from sixty-six suppliers. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-one drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 202784
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Hetero Labs Ltd Iii
Ingredient:esomeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202784
Suppliers and Packaging for NDA: 202784
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 202784 ANDA Camber Pharmaceuticals, Inc. 31722-572 31722-572-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-572-10)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 202784 ANDA Camber Pharmaceuticals, Inc. 31722-572 31722-572-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-572-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Sep 21, 2015TE:BXRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Sep 21, 2015TE:BXRLD:No

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