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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Fuji
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Novartis
US Army
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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203270

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NDA 203270 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 eleven 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-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 203270

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

Pharmacology for NDA: 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 16714-746-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-746-01)
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 203270 ANDA NorthStar Rx LLC 16714-747 16714-747-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-747-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Federal Trade Commission
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