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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203636

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NDA 203636 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs 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 twelve NDAs. It is available from sixty-two 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-eight suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 203636
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Torrent Pharms Ltd
Ingredient:esomeprazole magnesium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203636
Suppliers and Packaging for NDA: 203636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 203636 ANDA Torrent Pharmaceuticals Limited 13668-154 N 13668-154-05
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 203636 ANDA Torrent Pharmaceuticals Limited 13668-154 N 13668-154-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Oct 19, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Oct 19, 2015TE:ABRLD:No

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