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Generated: December 14, 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 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-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 075576

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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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Colorcon
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Julphar

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