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Last Updated: December 5, 2020

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Details for New Drug Application (NDA): 203270

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NDA 203270 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 203270
Tradename:OMEPRAZOLE
Applicant:Aurobindo Pharma Ltd
Ingredient:omeprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203270
Medical Subject Heading (MeSH) Categories for 203270
Suppliers and Packaging for NDA: 203270
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203270 ANDA NorthStar Rx LLC 16714-746 16714-746-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-746-01)
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203270 ANDA NorthStar Rx LLC 16714-747 16714-747-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-747-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Aug 19, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Aug 19, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Aug 19, 2015TE:ABRLD:No

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