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Serving leading biopharmaceutical companies globally:

Covington
Chubb
Farmers Insurance
US Army
Johnson and Johnson
Baxter
Moodys
Colorcon
Healthtrust
Cerilliant

Generated: January 22, 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, 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 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 16714-735-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-735-01)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 205606 ANDA NorthStar Rx LLC 16714-735 16714-735-02 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (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 leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Harvard Business School
US Department of Justice
Baxter
Chinese Patent Office
US Army
Chubb
Farmers Insurance

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