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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075876


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NDA 075876 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Cumberland, 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-four 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. Forty-eight suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 075876
Tradename:OMEPRAZOLE
Applicant:Strides Pharma
Ingredient:omeprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075876
Medical Subject Heading (MeSH) Categories for 075876
Suppliers and Packaging for NDA: 075876
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075876 ANDA Strides Pharma Science Limited 64380-222 64380-222-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (64380-222-01)
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075876 ANDA Strides Pharma Science Limited 64380-223 64380-223-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (64380-223-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:May 29, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:May 29, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 21, 2009TE:RLD:No

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