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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 022056


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NDA 022056 describes PRILOSEC, which is a drug marketed by Astrazeneca and Covis and is included in three NDAs. It is available from one supplier. Additional details are available on the PRILOSEC profile page.

The generic ingredient in PRILOSEC 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 022056
Tradename:PRILOSEC
Applicant:Covis
Ingredient:omeprazole magnesium
Patents:0
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 Covis Pharma US, Inc 70515-610 70515-610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01)
PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA Covis Pharma US, Inc 70515-625 70515-625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 2.5MG BASE/PACKET
Approval Date:Mar 20, 2008TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 10MG BASE/PACKET
Approval Date:Mar 20, 2008TE:RLD:Yes

Expired US Patents for NDA 022056

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ⤷  Sign Up ⤷  Sign Up
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 ⤷  Sign Up ⤷  Sign Up
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ⤷  Sign Up ⤷  Sign Up
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 ⤷  Sign Up ⤷  Sign Up
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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