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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200882

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NDA 200882 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Aurobindo Pharma Ltd, Deva Holding As, Mylan Labs Ltd, and Sun Pharma Global, and is included in five NDAs. It is available from four suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 200882
Tradename:ESOMEPRAZOLE SODIUM
Applicant:Sun Pharma Global
Ingredient:esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200882
Suppliers and Packaging for NDA: 200882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 200882 ANDA Sun Pharmaceutical Industries Limited 62756-508 N 62756-508-44
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 200882 ANDA Sun Pharmaceutical Industries Limited 62756-509 N 62756-509-44

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Mar 18, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 18, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
US Army
Harvard Business School
Queensland Health
Accenture
Teva
Fuji
Cantor Fitzgerald
Cerilliant

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