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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204655


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NDA 204655 describes NEXIUM 24HR, which is a drug marketed by Astrazeneca Lp and is included in two NDAs. It is available from two suppliers. Additional details are available on the NEXIUM 24HR profile page.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 204655
Tradename:NEXIUM 24HR
Applicant:Astrazeneca Lp
Ingredient:esomeprazole magnesium
Patents:0
Pharmacology for NDA: 204655
Suppliers and Packaging for NDA: 204655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Haleon US Holdings LLC 0573-2450 0573-2450-02 1 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Haleon US Holdings LLC 0573-2450 0573-2450-14 1 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 28, 2014TE:RLD:Yes

Expired US Patents for NDA 204655

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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