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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206877


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NDA 206877 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D, and is included in eight NDAs. It is available from forty-six suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 206877
Tradename:OMEPRAZOLE MAGNESIUM
Applicant:Aurobindo Pharma
Ingredient:omeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206877
Suppliers and Packaging for NDA: 206877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206877 ANDA WALGREEN CO. 0363-1008 0363-1008-05 1 BOTTLE in 1 CARTON (0363-1008-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206877 ANDA WALGREEN CO. 0363-1008 0363-1008-61 2 BOTTLE in 1 CARTON (0363-1008-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 6, 2018TE:RLD:No

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