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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Julphar
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Generated: August 22, 2017

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 Ivax Sub Teva Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Torrent Pharms Ltd, Dr Reddys Labs Ltd, and Hetero Labs Ltd Iii, and is included in six NDAs. It is available from nineteen suppliers. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

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

Summary for NDA: 203636

Tradename:
1
Applicant:
1
Ingredient:
1
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 13668-154-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-05)
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 203636 ANDA Torrent Pharmaceuticals Limited 13668-154 13668-154-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-10)

Summary for product number 001

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

Summary 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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Healthtrust
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QuintilesIMS

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