Details for New Drug Application (NDA): 211039
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NDA 211039 describes FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE, which is a drug marketed by Bausch Lomb Ireland and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE profile page.
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.
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: | 10,293,047 | 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: | 10,632,197 | 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: | 10,842,872 | 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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