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 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. Seven suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
The generic ingredient in PROLENSA is bromfenac sodium. Seven 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 | 24208-602-04 | 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: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Nov 19, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | See Plans and Pricing | Patent Expiration: | Jan 16, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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