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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson
Farmers Insurance
Argus Health

Generated: February 22, 2018

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 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 four suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy 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 205379
Applicant:Accord Hlthcare
Ingredient:esomeprazole sodium
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 esomeprazole sodium INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 N 16729-252-66
ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 N 16729-252-69

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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US Army
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Daiichi Sankyo

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