Details for New Drug Application (NDA): 203168
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The generic ingredient in PROLENSA is bromfenac sodium. 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: | 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: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 19, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 16, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
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 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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