Orange Book product · Brand (NDA)
XEPI
OZENOXACIN
Brand (NDA)NDA 208945DISCN LNHC
At a glance
Dec 11, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 2017
8 yr 8 mo ago
Today
Patent 9399014 expires
Listed method-of-use patent (U-805) expiration.
Dec 15, 2029
in 3 yr 7 mo
Patent 9180200 expires
Listed drug product patent expiration.
Jan 29, 2032
in 5 yr 8 mo
Pharmaceutical detail
Active ingredient
OZENOXACIN
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 208945
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9399014 | Dec 15, 2029 | in 3 yr 7 mo | U-805 |
| 9180200 | Jan 29, 2032 | in 5 yr 8 mo | ProductU-805 |
