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Serving leading biopharmaceutical companies globally:

Deloitte
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Cantor Fitzgerald
Accenture
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Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078279

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NDA 078279 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, Kremers Urban Pharms, Mylan Pharms Inc, Torrent Pharms Ltd, and Perrigo R And D, and is included in ten NDAs. It is available from fifty-seven 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-four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 078279
Tradename:ESOMEPRAZOLE MAGNESIUM
Applicant:Dr Reddys Labs Ltd
Ingredient:esomeprazole magnesium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078279
Suppliers and Packaging for NDA: 078279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 078279 ANDA Major Pharmaceuticals 0904-6580 0904-6580-61 100 BLISTER PACK in 1 CARTON (0904-6580-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 078279 ANDA Major Pharmaceuticals 0904-6581 0904-6581-68 60 BLISTER PACK in 1 CARTON (0904-6581-68) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Sep 25, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Sep 25, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
McKinsey
UBS
Cantor Fitzgerald
Dow
Merck
Farmers Insurance
Covington

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