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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022101


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NDA 022101 describes NEXIUM, which is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs. It is available from one supplier. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy-four 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 022101
Tradename:NEXIUM
Applicant:Astrazeneca
Ingredient:esomeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022101
Suppliers and Packaging for NDA: 022101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 NDA AstraZeneca Pharmaceuticals LP 0186-4010 0186-4010-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 10MG BASE/PACKET
Approval Date:Feb 27, 2008TE:ABRLD:Yes

Expired US Patents for NDA 022101

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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