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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091672

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NDA 091672 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 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-one 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: 091672

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

Pharmacology for NDA: 091672

Suppliers and Packaging for NDA: 091672

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 091672 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8079 0615-8079-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05)
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 091672 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8079 0615-8079-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Oct 31, 2014TE:ABRLD:No


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Mallinckrodt
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Moodys

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