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Generated: December 12, 2017

DrugPatentWatch Database Preview

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, 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 204657

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 55150-184 55150-184-05 10 VIAL in 1 CARTON (55150-184-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Aug 10, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Aug 10, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Fuji
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Daiichi Sankyo
Julphar
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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