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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204657

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NDA 204657 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. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 204657
Tradename:ESOMEPRAZOLE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204657
Suppliers and Packaging for NDA: 204657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657 ANDA AuroMedics Pharma LLC 55150-184 N 55150-184-05
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657 ANDA AuroMedics Pharma LLC 55150-185 N 55150-185-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Aug 10, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Aug 10, 2016TE:APRLD:No

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