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Details for New Drug Application (NDA): 091352

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NDA 091352 describes OMEPRAZOLE, which is a drug marketed by Kremers Urban Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Aurobindo Pharma Usa, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Lupin Ltd, Impax Labs, Gastroentero, Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, and Perrigo R And D, and is included in twenty-seven NDAs. It is available from one hundred suppliers. There is one patent 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 eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 091352

Tradename:
OMEPRAZOLE
Applicant:
Zydus Pharms Usa Inc
Ingredient:
omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091352

Suppliers and Packaging for NDA: 091352

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 091352 ANDA A-S Medication Solutions 50090-1371 50090-1371-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1371-0)
OMEPRAZOLE
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL 091352 ANDA A-S Medication Solutions 50090-1371 50090-1371-1 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1371-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Nov 19, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Nov 19, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Nov 19, 2012TE:ABRLD:No


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