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Details for New Drug Application (NDA): 074447
NDA 074447 describes FLURBIPROFEN SODIUM, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from four suppliers. Additional details are available on the FLURBIPROFEN SODIUM profile page.
The generic ingredient in FLURBIPROFEN SODIUM is flurbiprofen sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
The generic ingredient in FLURBIPROFEN SODIUM is flurbiprofen sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
Summary for 074447
| Tradename: | FLURBIPROFEN SODIUM |
| Applicant: | Bausch And Lomb |
| Ingredient: | flurbiprofen sodium |
| Patents: | 0 |
| Therapeutic Class: | Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074447
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 074447
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLURBIPROFEN SODIUM | flurbiprofen sodium | SOLUTION/DROPS;OPHTHALMIC | 074447 | ANDA | Bausch & Lomb Incorporated | 24208-314 | N | 24208-314-25 |
| FLURBIPROFEN SODIUM | flurbiprofen sodium | SOLUTION/DROPS;OPHTHALMIC | 074447 | ANDA | A-S Medication Solutions | 50090-0625 | N | 50090-0625-0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.03% | ||||
| Approval Date: | Jan 4, 1995 | TE: | AT | RLD: | No | ||||
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