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Details for New Drug Application (NDA): 021229

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NDA 021229 describes PRILOSEC OTC, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRILOSEC OTC profile page.

The generic ingredient in PRILOSEC OTC 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: 021229

Tradename:
PRILOSEC OTC
Applicant:
Astrazeneca Pharms
Ingredient:
omeprazole magnesium
Patents:4
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021229

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 021229 NDA The Procter & Gamble Manufacturing Company 37000-455 37000-455-01 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01)
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 021229 NDA The Procter & Gamble Manufacturing Company 37000-455 37000-455-02 1 BLISTER PACK in 1 CARTON (37000-455-02) > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 20, 2003TE:RLD:Yes
Patent:5,817,338Patent Expiration:Oct 6, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,900,424Patent Expiration:May 4, 2016Product Flag?Substance Flag?Delist Request?
Patent:6,403,616Patent Expiration:Nov 15, 2019Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021229

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20034,738,974► subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,753,265► subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,900,424► 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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