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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021229


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NDA 021229 describes PRILOSEC OTC, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. 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. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 021229
Tradename:PRILOSEC OTC
Applicant:Astrazeneca
Ingredient:omeprazole magnesium
Patents:0
Pharmacology for NDA: 021229
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

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 20, 2003TE:RLD:Yes

Expired US Patents for NDA 021229

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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