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Last Updated: January 23, 2020

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Details for New Drug Application (NDA): 206877

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NDA 206877 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Dr Reddys Labs Ltd, Spil, Aurobindo Pharma Ltd, and Perrigo R And D, and is included in four NDAs. It is available from thirty 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. Thirty-four 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 Ltd
Ingredient:omeprazole magnesium
Patents:0
Formulation / Manufacturing:see details
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 7-Eleven 10202-722 10202-722-05 1 BOTTLE in 1 CARTON (10202-722-05) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206877 ANDA Bi-Mart 37835-189 37835-189-14 1 BOTTLE in 1 CARTON (37835-189-14) > 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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