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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203349

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NDA 203349 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 203349
Tradename:ESOMEPRAZOLE SODIUM
Applicant:Gland Pharma Ltd
Ingredient:esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203349
Suppliers and Packaging for NDA: 203349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 203349 ANDA Gland Pharma Limited 68083-451 68083-451-10 10 VIAL in 1 CARTON (68083-451-10) > 5 mL in 1 VIAL (68083-451-01)
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 203349 ANDA Gland Pharma Limited 68083-452 68083-452-10 10 VIAL in 1 CARTON (68083-452-10) > 5 mL in 1 VIAL (68083-452-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Apr 1, 2020TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Apr 1, 2020TE:APRLD:No

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