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Serving 500+ biopharmaceutical companies globally:

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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078003

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NDA 078003 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 twenty-three 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. Thirty suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for NDA: 078003

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078003

Suppliers and Packaging for NDA: 078003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 078003 ANDA Teva Pharmaceuticals USA, Inc. 0093-6450 0093-6450-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6450-10)
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 078003 ANDA Teva Pharmaceuticals USA, Inc. 0093-6450 0093-6450-56 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6450-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jan 26, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Jan 26, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Baxter
Cerilliant
McKinsey
Citi
Colorcon
Julphar
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Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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