Details for New Drug Application (NDA): 019810

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NDA 019810 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 suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 019810

Tradename:	PRILOSEC
Applicant:	Astrazeneca
Ingredient:	omeprazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 019810

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 14, 1989	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 15, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 5, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 019810

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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