FDA Orange Book · active-ingredient family
Benoxinate hydrochloride; fluorescein sodium
Benoxinate hydrochloride; fluorescein sodium is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE · NDA 211039
2
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDERLD | BAUSCH LOMB IRELAND | NDA 211039 | — | Mar 09, 2020 | |
| ALTAFLUOR BENOXRLD | ALTAIRE PHARMS INC | NDA 208582 | — | Dec 14, 2017 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10842872 | Nov 15, 2037 | in 11 yr 7 mo | U-3001 |
| 10632197 | Nov 15, 2037 | in 11 yr 7 mo | ProductU-2755 |
| 10293047 | Nov 15, 2037 | in 11 yr 7 mo | ProductU-2755 |
Benoxinate hydrochloride; fluorescein sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
