Orange Book product · Brand (NDA)
TEMOVATE
CLOBETASOL PROPIONATE
At a glance
Feb 22, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 22, 1990
36 yr 10 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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 019966
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
- 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
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.
