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Details for New Drug Application (NDA): 203168
NDA 203168 describes PROLENSA, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are nine 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. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
The generic ingredient in PROLENSA is bromfenac sodium. Five 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: | 9 |
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 | 24208-602-06 | 1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) > .6 mL in 1 BOTTLE, DROPPER |
Paragraph IV (Patent) Challenges for 203168
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROLENSA | SOLUTION/DROPS;OPHTHALMIC | bromfenac sodium | 203168 | 2013-07-26 |
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: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Nov 19, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Jan 16, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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