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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022032

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NDA 022032 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Kremers Urban Pharms, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Gastroentero, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc, and is included in thirty-two NDAs. It is available from one hundred and eight suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the OMEPRAZOLE profile page.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 022032

Tradename:	OMEPRAZOLE
Applicant:	Dexcel Pharma
Ingredient:	omeprazole
Patents:	1
Therapeutic Class:	Gastrointestinal Agents
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 022032

Anti-Ulcer Agents
Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022032

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032	NDA	L. Perrigo Company	0113-0915	N	0113-0915-03
OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032	NDA	L. Perrigo Company	0113-0915	N	0113-0915-30

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Dec 4, 2007	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Aug 16, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

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Chinese Patent Office

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US Department of Justice

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