Details for New Drug Application (NDA): 021229

✉ Email this page to a colleague

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-three 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

Subscribe to access the full database, or Get Started Free
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	5,900,424	⤷ Get Started Free
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	4,738,974	⤷ Get Started Free
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	6,403,616	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.