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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021689

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NDA 021689 describes NEXIUM IV, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the NEXIUM IV profile page.

The generic ingredient in NEXIUM IV is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 021689
Tradename:NEXIUM IV
Applicant:Astrazeneca Pharms
Ingredient:esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021689
Suppliers and Packaging for NDA: 021689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689 NDA AstraZeneca Pharmaceuticals LP 0186-6040 0186-6040-01 10 VIAL in 1 CARTON (0186-6040-01) > 5 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 021689
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM IV INJECTABLE;INTRAVENOUS esomeprazole sodium 021689 2009-11-23

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 31, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 31, 2005TE:APRLD:Yes

Expired US Patents for NDA 021689

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Baxter
Express Scripts
Medtronic
Boehringer Ingelheim

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