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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205379

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NDA 205379 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Deva Holding As, and Sun Pharma Global, and is included in four 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-seven 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 NDA: 205379

Formulation / Manufacturing:see details

Pharmacology for NDA: 205379

Suppliers and Packaging for NDA: 205379

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
esomeprazole sodium
INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 16729-252-66 1 VIAL in 1 CARTON (16729-252-66) > 5 mL in 1 VIAL
esomeprazole sodium
INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 16729-252-69 10 VIAL in 1 CARTON (16729-252-69) > 5 mL in 1 VIAL

Summary for product number 001

Approval Date:Sep 25, 2015TE:APRLD:No

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