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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075576

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NDA 075576 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, 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 twenty-nine NDAs. It is available from one hundred and five 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: 075576

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

Pharmacology for NDA: 075576

Suppliers and Packaging for NDA: 075576

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 075576 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2302 0615-2302-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-2302-05)
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 075576 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2302 0615-2302-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-2302-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 21, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Oct 22, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Oct 22, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Novartis
Julphar
US Army
Citi
Daiichi Sankyo
US Department of Justice
Farmers Insurance
Boehringer Ingelheim

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