Orange Book product · Brand (NDA)
TOPICORT
DESOXIMETASONE
At a glance
Sep 30, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1983
43 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DESOXIMETASONE
Strength
0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 018763
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.
- 2013TOPICORTBrand (NDA)
NDA 204141 · SUN PHARMA CANADA
- 1985TOPICORTBrand (NDA)
NDA 018594 · TARO
- 1982TOPICORTBrand (NDA)
NDA 018586 · TARO
- —TOPICORTBrand (NDA)
NDA 017856 · TARO
- —TOPICORT LPBrand (NDA)
NDA 018309 · TARO
- 2020DESOXIMETASONEGeneric (ANDA)
ANDA 209595 · COSETTE
- 2018DESOXIMETASONEGeneric (ANDA)
ANDA 210980 · RISING
- 2018DESOXIMETASONEGeneric (ANDA)
ANDA 209973 · THE J MOLNER
- 2018DESOXIMETASONEGeneric (ANDA)
ANDA 205620 · ZYDUS LIFESCIENCES
- 2018DESOXIMETASONEGeneric (ANDA)
ANDA 205594 · RISING
- 2018DESOXIMETASONEGeneric (ANDA)
ANDA 208124 · LUPIN
- 2017DESOXIMETASONEGeneric (ANDA)
ANDA 205206 · ZYDUS LIFESCIENCES
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.
