Orange Book product · Brand (NDA)
LUZU
LULICONAZOLE
At a glance
Nov 14, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2013
12 yr 9 mo ago
Today
Patent 9012484 expires
Listed drug substance patent expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 9199977 expires
Listed drug substance patent expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 9453006 expires
Listed drug substance patent expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 8980931 expires
Listed drug product patent expiration.
Apr 28, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
LULICONAZOLE
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 204153
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9012484 | Sep 06, 2033 | in 7 yr 4 mo | SubstanceProductU-540 |
| 9199977 | Sep 06, 2033 | in 7 yr 4 mo | SubstanceProduct |
| 9453006 | Sep 06, 2033 | in 7 yr 4 mo | Substance |
| 8980931 | Apr 28, 2034 | in 8 yr | Product |
