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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022032

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NDA 022032 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Apotex Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Cumberland Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Zydus Pharms, and Spil, and is included in forty NDAs. It is available from ninety-two suppliers. There are two patents 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 thirty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 022032
Tradename:OMEPRAZOLE
Applicant:Dexcel Pharma
Ingredient:omeprazole
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022032
Suppliers and Packaging for NDA: 022032
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 022032 NDA L. Perrigo Company 0113-0915 0113-0915-03 3 BOTTLE in 1 CARTON (0113-0915-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 022032 NDA L. Perrigo Company 0113-0915 0113-0915-30 2 CARTON in 1 CARTON (0113-0915-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022032
Tradename Dosage Ingredient NDA Submissiondate
OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL omeprazole 022032

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Dec 4, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 16, 2025Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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Dow

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