Orange Book product · Brand (NDA)
OLUX E
CLOBETASOL PROPIONATE
At a glance
Jan 12, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2007
19 yr 9 mo ago
Today
Patent 8460641 expires
Listed drug product patent expiration.
Nov 05, 2028
in 2 yr 5 mo
Pharmaceutical detail
Active ingredient
CLOBETASOL PROPIONATE
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
AEROSOL, FOAM
Route
TOPICAL
TE code
Not listed
Application
NDA 022013
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.
- 2020IMPEKLOBrand (NDA)
NDA 213691 · PHARMOBEDIENT
- 2017IMPOYZBrand (NDA)
NDA 209483 · PRIMUS PHARMS
- 2003CLOBEXBrand (NDA)
NDA 021535 · GALDERMA LABS LP
- 2000OLUXBrand (NDA)
NDA 021142 · PHARMOBEDIENT
- 1994TEMOVATE EBrand (NDA)
NDA 020340 · FOUGERA PHARMS
- 1994TEMOVATEBrand (NDA)
NDA 020337 · FOUGERA PHARMS
- 1985TEMOVATEBrand (NDA)
NDA 019322 · FOUGERA PHARMS
- 2025CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 210638 · XIROMED
- 2024CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 208563 · TARO
- 2022CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 215838 · ALEMBIC
- 2021CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 211207 · CHARTWELL RX
- 2020CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 212982 · ENCUBE
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8460641 | Nov 05, 2028 | in 2 yr 5 mo | ProductU-1410 |
