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

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Moodys
Daiichi Sankyo
Farmers Insurance
Julphar
Fish and Richardson
Healthtrust
Dow
Cerilliant

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078490

« Back to Dashboard

NDA 078490 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, Lannett Co Inc, 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 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-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 078490
Tradename:OMEPRAZOLE
Applicant:Dr Reddys Labs Ltd
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078490
Medical Subject Heading (MeSH) Categories for 078490
Suppliers and Packaging for NDA: 078490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 078490 ANDA Dr. Reddy's Laboratories Limited 55111-643 N 55111-643-01
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 078490 ANDA Dr. Reddy's Laboratories Limited 55111-643 N 55111-643-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Apr 17, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Mar 16, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Mar 16, 2009TE: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:

Colorcon
Healthtrust
Fuji
Moodys
Dow
Express Scripts
Cipla
Citi
Chubb

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.