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Last Updated: November 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209400

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NDA 209400 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, Dexcel Pharma, Dr Reddys, Sun Pharm, Cumberland Pharms, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Unicorn, Zydus Pharms, Spil, and P And L, and is included in forty-three NDAs. It is available from eighty-five 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-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 209400
Tradename:OMEPRAZOLE
Applicant:Dexcel Pharma
Ingredient:omeprazole
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209400
Suppliers and Packaging for NDA: 209400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 209400 NDA L. Perrigo Company 0113-0520 0113-0520-55 3 CARTON in 1 CARTON (0113-0520-55) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
OMEPRAZOLE omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 209400 NDA L. Perrigo Company 0113-0520 0113-0520-74 14 BLISTER PACK in 1 CARTON (0113-0520-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength20MG
Approval Date:Jul 5, 2017TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Dec 8, 2036Product Flag?YSubstance Flag?Delist Request?

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