FDA Orange Book · active-ingredient family
Oxymetazoline hydrochloride; tetracaine hydrochloride
Oxymetazoline hydrochloride; tetracaine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KOVANAZE · NDA 208032
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KOVANAZERLD | ST RENATUS | NDA 208032 | — | Jun 29, 2016 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9308191 | Apr 02, 2030 | in 3 yr 10 mo | ProductU-1876 |
| 8580282 | Apr 02, 2030 | in 3 yr 10 mo | ProductU-1876 |
Oxymetazoline hydrochloride; tetracaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
