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Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205606

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NDA 205606 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hec Pharm Co Ltd, 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-five suppliers. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 205606
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:esomeprazole magnesium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205606
Suppliers and Packaging for NDA: 205606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 205606 ANDA NorthStar Rx LLC 16714-735 N 16714-735-01
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 205606 ANDA NorthStar Rx LLC 16714-735 N 16714-735-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Apr 21, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Apr 21, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Dow
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Fish and Richardson
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