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Last Updated: December 8, 2019

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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 two suppliers. There are two 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 thirty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 021229
Tradename:PRILOSEC OTC
Applicant:Astrazeneca Pharms
Ingredient:omeprazole magnesium
Patents:2
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
Paragraph IV (Patent) Challenges for 021229
Tradename Dosage Ingredient NDA Submissiondate
PRILOSEC OTC TABLET, DELAYED RELEASE;ORAL omeprazole magnesium 021229 2012-03-30
PRILOSEC OTC TABLET, DELAYED RELEASE;ORAL omeprazole magnesium 021229 2007-03-19

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 20, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 15, 2019Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 3, 2019Product Flag?Substance Flag?Delist Request?

Expired US 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;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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