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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 207740


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NDA 207740 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Norvium Bioscience, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Perrigo R And D, Sciegen Pharms Inc, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, and P And L, and is included in forty-six NDAs. It is available from ninety-nine suppliers. There are three 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. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 207740
Tradename:OMEPRAZOLE
Applicant:Dr Reddys
Ingredient:omeprazole
Patents:0
Pharmacology for NDA: 207740
Medical Subject Heading (MeSH) Categories for 207740
Suppliers and Packaging for NDA: 207740
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 207740 ANDA Walgreens Company 0363-1607 0363-1607-14 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 207740 ANDA Walgreens Company 0363-1607 0363-1607-28 2 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Nov 5, 2018TE:RLD:No

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