Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Cantor Fitzgerald
Healthtrust
Chinese Patent Office
Cipla
Queensland Health
Chubb
Farmers Insurance
Julphar

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203270

« Back to Dashboard

NDA 203270 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 203270
Tradename:OMEPRAZOLE
Applicant:Aurobindo Pharma Ltd
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203270
Medical Subject Heading (MeSH) Categories for 203270
Suppliers and Packaging for NDA: 203270
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203270 ANDA NorthStar Rx LLC 16714-746 N 16714-746-01
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203270 ANDA NorthStar Rx LLC 16714-747 N 16714-747-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Aug 19, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Aug 19, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Aug 19, 2015TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Baxter
Argus Health
Julphar
Healthtrust
Deloitte
Cerilliant
Fuji

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.