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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022032

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NDA 022032 describes OMEPRAZOLE, which is a drug marketed by Kremers Urban Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Teva Pharms Usa, Aurobindo Pharma Ltd, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Breckenridge Pharm, Lupin Ltd, Impax Labs, Gastroentero, Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc, and is included in thirty NDAs. It is available from one hundred and seven 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-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 022032

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

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 0113-0915-01 14 BOTTLE in 1 CARTON (0113-0915-01) > 1 TABLET, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE
omeprazole
TABLET, DELAYED RELEASE;ORAL 022032 NDA L. Perrigo Company 0113-0915 0113-0915-30 2 CARTON in 1 CARTON (0113-0915-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Dec 4, 2007TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 16, 2025Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Deloitte
Citi
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Harvard Business School
Julphar
Farmers Insurance
QuintilesIMS
Federal Trade Commission

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. thinkBiotech performs no independent verifification 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.

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