Orange Book product · Brand (NDA)
ULTRAVATE
HALOBETASOL PROPIONATE
At a glance
Dec 27, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
HALOBETASOL 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0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019967
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.
- 2018BRYHALIBrand (NDA)
NDA 209355 · BAUSCH
- 2018LEXETTEBrand (NDA)
NDA 210566 · MAYNE PHARMA
- 2015ULTRAVATEBrand (NDA)
NDA 208183 · LACER PHARMA
- 1990ULTRAVATEBrand (NDA)
NDA 019968 · SUN PHARM INDS INC
- 2023HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 215266 · PADAGIS ISRAEL
- 2020HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 213560 · QUAGEN
- 2020HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 211464 · PADAGIS ISRAEL
- 2018HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 209978 · ENCUBE
- 2007HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 078162 · COSETTE PHARMS NC
- 2006HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 077721 · COSETTE
- 2005HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 077227 · SUN PHARMA CANADA
- 2005HALOBETASOL PROPIONATEGeneric (ANDA)
ANDA 077109 · COSETTE PHARMS NC
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.
