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Last Updated: March 1, 2024

Details for New Drug Application (NDA): 018841

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NDA 018841 describes DAYPRO, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. Additional details are available on the DAYPRO profile page.

The generic ingredient in DAYPRO is oxaprozin potassium. There are thirteen drug master file entries for this compound. Additional details are available on the oxaprozin potassium profile page.
Summary for 018841
Formulation / Manufacturing:see details
Pharmacology for NDA: 018841
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 018841
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAYPRO oxaprozin TABLET;ORAL 018841 NDA Pfizer Laboratories Div Pfizer Inc 0025-1381 0025-1381-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1381-31)
DAYPRO oxaprozin TABLET;ORAL 018841 NDA AUTHORIZED GENERIC Greenstone LLC 59762-6002 59762-6002-1 100 TABLET, FILM COATED in 1 BOTTLE (59762-6002-1)

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 29, 1992TE:ABRLD:Yes

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