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Last Updated: November 22, 2024

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.
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 ActionDyes
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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.4%;0.3%
Approval Date:Mar 9, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 15, 2037Product Flag?YSubstance 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 UpPatent Expiration:Nov 15, 2037Product Flag?YSubstance 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 UpPatent Expiration:Nov 15, 2037Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.