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Details for New Drug Application (NDA): 021153

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NDA 021153 describes NEXIUM, which is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from fourteen suppliers. There are nine patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are sixty drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for NDA: 021153

Tradename:
NEXIUM
Applicant:
Astrazeneca Pharms
Ingredient:
esomeprazole magnesium
Patents:9
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Feb 20, 2001TE:ABRLD:No
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:6,147,103*PEDPatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021153

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20016,875,872*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20014,738,974*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20015,877,192*PED<disabled>
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