Orange Book product · Brand (NDA)
WYNZORA
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
At a glance
Jul 20, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 20, 2020
6 yr ago
Today
Patent 10265265 expires
Listed drug product patent expiration.
Sep 27, 2027
in 1 yr 4 mo
Patent 11696919 expires
Listed drug product patent expiration.
Mar 18, 2039
in 12 yr 11 mo
Patent 12440499 expires
Listed drug product patent expiration.
Mar 18, 2039
in 12 yr 11 mo
Pharmaceutical detail
Active ingredient
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Strength
0.064%;0.005%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 213422
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.
- 2015ENSTILARBrand (NDA)
NDA 207589 · LEO PHARMA AS
- 2008TACLONEXBrand (NDA)
NDA 022185 · 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 (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10265265 | Sep 27, 2027 | in 1 yr 4 mo | Product |
| 11696919 | Mar 18, 2039 | in 12 yr 11 mo | Product |
| 12440499 | Mar 18, 2039 | in 12 yr 11 mo | ProductU-1408 |
