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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200882

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NDA 200882 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 five suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are sixty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 200882

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200882

Suppliers and Packaging for NDA: 200882

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 200882 ANDA Sun Pharma Global FZE 47335-508 47335-508-44 10 VIAL, SINGLE-USE in 1 CARTON (47335-508-44) > 5 mL in 1 VIAL, SINGLE-USE (47335-508-40)
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 200882 ANDA Sun Pharma Global FZE 47335-509 47335-509-44 10 VIAL, SINGLE-USE in 1 CARTON (47335-509-44) > 5 mL in 1 VIAL, SINGLE-USE (47335-509-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Mar 18, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 18, 2013TE:APRLD:No


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