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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 one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEXIUM 24HR profile page.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are sixty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for NDA: 204655

Tradename:
NEXIUM 24HR
Applicant:
Astrazeneca Lp
Ingredient:
esomeprazole magnesium
Patents:5
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

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 Pfizer Consumer Healthcare 0573-2450 0573-2450-14 1 BOTTLE in 1 CARTON (0573-2450-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Pfizer Consumer Healthcare 0573-2450 0573-2450-15 1 BOTTLE in 1 BLISTER PACK (0573-2450-15) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 28, 2014TE:RLD:Yes
Patent:5,714,504*PEDPatent Expiration:Aug 3, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,900,424*PEDPatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,369,085*PEDPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;ORAL204655-001Mar 28, 20145,690,960*PED► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20146,875,872*PED► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,900,424*PED► subscribe
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