Details for New Drug Application (NDA): 203168
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NDA 203168 describes PROLENSA, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PROLENSA profile page.
The generic ingredient in PROLENSA is bromfenac sodium. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
The generic ingredient in PROLENSA is bromfenac sodium. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 203168
| Tradename: | PROLENSA |
| Applicant: | Bausch And Lomb |
| Ingredient: | bromfenac sodium |
| Patents: | 2 |
Pharmacology for NDA: 203168
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 203168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168 | NDA | Bausch & Lomb Incorporated | 24208-602 | 24208-602-03 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER |
| PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168 | NDA | Bausch & Lomb Incorporated | 24208-602 | 24208-602-04 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.07% ACID | ||||
| Approval Date: | Apr 5, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 19, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 11, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY | ||||||||
Expired US Patents for NDA 203168
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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