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 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

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

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:	OTC	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 20, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021229

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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
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