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Medtronic
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Generated: August 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208333

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NDA 208333 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 208333
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Alkem Labs Ltd
Ingredient:esomeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208333
Suppliers and Packaging for NDA: 208333
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 208333 ANDA Ascend Laboratories, LLC 67877-478 N 67877-478-05
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 208333 ANDA Ascend Laboratories, LLC 67877-478 N 67877-478-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Oct 20, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Oct 20, 2017TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Covington
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Cantor Fitzgerald
Accenture
Queensland Health
Baxter
Dow
McKesson

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