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Details for New Drug Application (NDA): 022056

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NDA 022056 describes PRILOSEC, which is a drug marketed by Astrazeneca Pharms and is included in three NDAs. It is available from three suppliers. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRILOSEC profile page.

The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 022056

Tradename:
PRILOSEC
Applicant:
Astrazeneca Pharms
Ingredient:
omeprazole magnesium
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 022056

Suppliers and Packaging for NDA: 022056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA AstraZeneca Pharmaceuticals LP 0186-0610 0186-0610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-0610-01)
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA AstraZeneca Pharmaceuticals LP 0186-0625 0186-0625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-0625-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 2.5MG BASE/PACKET
Approval Date:Mar 20, 2008TE:RLD:No
Patent:5,900,424Patent Expiration:May 4, 2016Product Flag?Substance Flag?YDelist Request?
Patented Use:PEDIATRIC USE AGES 1 MONTH TO 2 YEARS, GERD AND EROSIVE ESOPHAGITIS
Patent:6,428,810Patent Expiration:Nov 3, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PEDIATRIC USE AGES 1 MONTH TO 2 YEARS, GERD AND EROSIVE ESOPHAGITIS
Patent:5,900,424Patent Expiration:May 4, 2016Product Flag?Substance Flag?YDelist Request?
Patented Use:PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS

Expired Orange Book Patents for NDA: 022056

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 20085,690,960► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 20085,900,424► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 20085,690,960► subscribe
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