Orange Book product · Brand (NDA)

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

Brand (NDA)NDA 211039RX BAUSCH LOMB IRELAND

Mar 09, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 09, 2020
6 yr 4 mo ago
Today
Patent 10293047 expires
Listed drug product patent expiration.
Nov 15, 2037
in 11 yr 7 mo
Patent 10632197 expires
Listed drug product patent expiration.
Nov 15, 2037
in 11 yr 7 mo
Patent 10842872 expires
Listed method-of-use patent (U-3001) expiration.
Nov 15, 2037
in 11 yr 7 mo

Active ingredient

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

Strength

0.4%;0.3%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 211039

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10293047	Nov 15, 2037	in 11 yr 7 mo	ProductU-2755
10632197	Nov 15, 2037	in 11 yr 7 mo	ProductU-2755
10842872	Nov 15, 2037	in 11 yr 7 mo	U-3001