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Last Updated: April 18, 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. Forty-nine 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022056

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

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:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 2.5MG BASE/PACKET
Approval Date:	Mar 20, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 10MG BASE/PACKET
Approval Date:	Mar 20, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 022056

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

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