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Generated: October 22, 2017

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 Ivax Sub Teva Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Torrent Pharms Ltd, Kremers Urban Pharms, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, and Perrigo R And D, and is included in eight NDAs. It is available from forty-seven suppliers. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are sixty-nine drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for NDA: 205606

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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

Summary 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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