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Last Updated: August 4, 2020

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, Gland Pharma Ltd, Mylan Labs Ltd, and Sun Pharma Global, and is included in six NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 207181
Applicant:Deva Holding As
Ingredient:esomeprazole sodium
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

Approval Date:Mar 6, 2017TE:APRLD:No

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