Orange Book product · Brand (NDA)
CLOBEX
CLOBETASOL PROPIONATE
At a glance
Oct 27, 2005
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 2005
20 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOBETASOL PROPIONATE
Strength
0.05%
Dosage form
SPRAY
Route
TOPICAL
TE code
AT
Application
NDA 021835
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.
- 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.
