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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 021153


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NDA 021153 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. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 021153
Tradename:NEXIUM
Applicant:Astrazeneca
Ingredient:esomeprazole magnesium
Patents:0
Pharmacology for NDA: 021153
Suppliers and Packaging for NDA: 021153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153 NDA AstraZeneca Pharmaceuticals LP 0186-5020 0186-5020-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31)
NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153 NDA AstraZeneca Pharmaceuticals LP 0186-5020 0186-5020-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Feb 20, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 40MG BASE
Approval Date:Feb 20, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021153

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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