Orange Book product · Brand (NDA)
TEMOVATE
CLOBETASOL PROPIONATE
At a glance
Dec 27, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1985
41 yr 1 mo ago
Today
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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019322
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
- 2007OLUX EBrand (NDA)
NDA 022013 · PHARMOBEDIENT
- 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
- 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
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
