Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207181

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NDA 207181 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-four 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 207181
Tradename:ESOMEPRAZOLE SODIUM
Applicant:Deva Holding As
Ingredient:esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207181
Suppliers and Packaging for NDA: 207181
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 207181 ANDA Akorn, Inc. 17478-850 17478-850-10 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-850-10) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 6, 2017TE:APRLD:No

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