Orange Book product · Brand (NDA)
TACLONEX
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
At a glance
May 09, 2008
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 09, 2008
18 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Strength
0.064%;0.005%
Dosage form
SUSPENSION
Route
TOPICAL
TE code
AB
Application
NDA 022185
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.
- 2020WYNZORABrand (NDA)
NDA 213422 · MC2
- 2015ENSTILARBrand (NDA)
NDA 207589 · LEO PHARMA AS
- 2006TACLONEXBrand (NDA)
NDA 021852 · LEO PHARMA AS
- 2023CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 214688 · GLENMARK PHARMS LTD
- 2020CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 212367 · PADAGIS ISRAEL
- 2020CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 213269 · SUN PHARMA CANADA
- 2020CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 210765 · COSETTE PHARMS NC
- 2014CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 200174 · PADAGIS ISRAEL
- 2013CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 201615 · 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.
