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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Cipla
Fish and Richardson
Dow
US Department of Justice
Chinese Patent Office
Fuji
Healthtrust
Merck

Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075410

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NDA 075410 describes OMEPRAZOLE, which is a drug marketed by Dexcel Pharma, Kremers Urban Pharms, Sandoz, 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-one NDAs. It is available from one hundred and nine 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-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 075410

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075410

Suppliers and Packaging for NDA: 075410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 075410 ANDA KAISER FOUNDATION HOSPITALS 0179-1804 0179-1804-70 30 CAPSULE, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0179-1804-70)
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 075410 ANDA Corporacion Infarmasa 16853-1308 16853-1308-1 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Nov 1, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Nov 1, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 23, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Dow
Johnson and Johnson
US Army
McKinsey
Chubb
Argus Health
Express Scripts
QuintilesIMS

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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