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 three 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.
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
| Tradename: | DAYPRO |
| Applicant: | Pfizer |
| Ingredient: | oxaprozin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018841
| Mechanism of Action | Cyclooxygenase 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 | PD-Rx Pharmaceuticals, Inc. | 55289-453 | 55289-453-14 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-453-14) |
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Oct 29, 1992 | TE: | AB | RLD: | Yes | ||||
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