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Last Updated: September 19, 2020

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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, 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 204657
Applicant:Aurobindo Pharma Ltd
Ingredient:esomeprazole sodium
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 55150-185 55150-185-05 10 VIAL in 1 CARTON (55150-185-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Approval Date:Aug 10, 2016TE:RLD:No

Profile for product number 002

Approval Date:Aug 10, 2016TE:APRLD:No

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