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Details for New Drug Application (NDA): 207920

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NDA 207920 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: 207920

Tradename:
NEXIUM 24HR
Applicant:
Astrazeneca Lp
Ingredient:
esomeprazole magnesium
Patents:4
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 207920

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 207920 NDA Pfizer Consumer Healthcare 0573-2451 0573-2451-14 1 BOTTLE in 1 CARTON (0573-2451-14) > 14 TABLET in 1 BOTTLE
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 207920 NDA Pfizer Consumer Healthcare 0573-2451 0573-2451-42 3 BOTTLE in 1 BLISTER PACK (0573-2451-42) > 14 TABLET in 1 BOTTLE

Summary for product number 01

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Nov 23, 2015TE:RLD:Yes
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
Patent:6,428,810*PEDPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 207920

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 20155,900,424*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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