Orange Book product · Brand (NDA)
DOVONEX
CALCIPOTRIENE
At a glance
Dec 29, 1993
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1993
32 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCIPOTRIENE
Strength
0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
TOPICAL
TE code
AB
Application
NDA 020273
Product number
001
Marketing status
RX
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.
- 2010SORILUXBrand (NDA)
NDA 022563 · MAYNE PHARMA
- 1997DOVONEXBrand (NDA)
NDA 020611 · LEO PHARM
- 1996DOVONEXBrand (NDA)
NDA 020554 · LEO PHARMA AS
- 2017CALCIPOTRIENEGeneric (ANDA)
ANDA 207163 · CHARTWELL RX
- 2015CALCIPOTRIENEGeneric (ANDA)
ANDA 205772 · GLENMARK SPECLT
- 2012CALCIPOTRIENEGeneric (ANDA)
ANDA 200935 · CHARTWELL RX
- 2011CALCIPOTRIENEGeneric (ANDA)
ANDA 078468 · COSETTE PHARMS NC
- 2010CALCIPOTRIENEGeneric (ANDA)
ANDA 090633 · GLENMARK PHARMS
- 2009CALCIPOTRIENEGeneric (ANDA)
ANDA 077029 · CHARTWELL RX
- 2009CALCIPOTRIENEGeneric (ANDA)
ANDA 077579 · HIKMA
- 2008CALCIPOTRIENEGeneric (ANDA)
ANDA 078305 · FOUGERA PHARMS
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.
