Details for New Drug Application (NDA): 211039
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The generic ingredient in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
Summary for 211039
Tradename: | FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE |
Applicant: | Bausch Lomb Ireland |
Ingredient: | benoxinate hydrochloride; fluorescein sodium |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211039
Generic Entry Date for 211039*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211039
Mechanism of Action | Dyes |
Suppliers and Packaging for NDA: 211039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | benoxinate hydrochloride; fluorescein sodium | SOLUTION/DROPS;OPHTHALMIC | 211039 | NDA | Bausch & Lomb Incorporated | 24208-734 | 24208-734-05 | 1 BOTTLE, GLASS in 1 CARTON (24208-734-05) / 5 mL in 1 BOTTLE, GLASS |
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | benoxinate hydrochloride; fluorescein sodium | SOLUTION/DROPS;OPHTHALMIC | 211039 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-732 | 68682-732-05 | 1 BOTTLE, GLASS in 1 CARTON (68682-732-05) / 5 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.4%;0.3% | ||||
Approval Date: | Mar 9, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 15, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 15, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 15, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PROCEDURES IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC. |
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