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Esomeprazole sodium - Generic Drug Details

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Esomeprazole sodium is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Sun Pharma Global, and Astrazeneca Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty drug master file entries for esomeprazole sodium. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: esomeprazole sodium

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list60
Suppliers / Packaging: see list6
Formulation / Manufacturing:see details

Pharmacology for Ingredient: esomeprazole sodium

Tentative approvals for ESOMEPRAZOLE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION40MG

Clinical Trials for: esomeprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 2005RXYes<disabled><disabled>
Sun Pharma Global
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS200882-002Mar 18, 2013RXNo<disabled><disabled>
Aurobindo Pharma Ltd
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS204657-002Aug 10, 2016RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: esomeprazole sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 20055,877,192*PED<disabled>
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 20056,143,771<disabled>
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 20056,143,771<disabled>
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