Betamethasone / calcipotriene Topical Foam
- Brand(s)
- Enstilar
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Leo Pharma Inc. (2015-10-29)
- Oldest Current Product
- 2015-10-16
- License(s)
- NDA
- RxNORM
- TOPICAL FOAM\BETAMETHASONE:CALCIPOTRIENE
- FDAOB
- TOPICAL\AEROSOL, FOAM\BETAMETHASONE DIPROPIONATE: CALCIPOTRIENE
- SPL Active
- TOPICAL\AEROSOL, FOAM\BETAMETHASONE DIPROPIONATE: CALCIPOTRIENE HYDRATE
- SPL Moiety
- TOPICAL\AEROSOL, FOAM\BETAMETHASONE: CALCIPOTRIENE
product(s) by strength(s)
betamethasone dipropionate 0.643 mg/ml / calcipotriene 0.05 mg/ml topical foam
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 502220302 | Enstilar | NDA | Leo Pharma Inc. | 2015-10-16 | BETAMETHASONE DIPROPIONATE, CALCIPOTRIENE HYDRATE | TOPICAL | AEROSOL, FOAM | NDA207589 | d1193df2-d53f-4342-bd9d-d9cba7c89709 |
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|
| 1 | NDA207589 | ENSTILAR | LEO PHARMA AS | 2015-10-16 | p9119781, PLAQUE PSORIASIS, SUBSTANCE
p6753013, PLAQUE PSORIASIS, SUBSTANCE | NEW PRODUCT [2018-10-16] | NDA207589_001 |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | NDA207589_001 | RX | CALCIPOTRIENE (0.005%), BETAMETHASONE DIPROPIONATE (0.064%) | TOPICAL | AEROSOL, FOAM | True | 2015-10-16 | ENSTILAR |
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|
| 1 | d1193df2-d53f-4342-bd9d-d9cba7c89709 (view SPL) | These highlights do not include all the information needed to use ENSTILARFoam safely and effectively. See Full Prescribing Information for ENSTILARFoam. ENSTILAR (calcipotriene and betamethasone dipropionate)Foam, 0.005%/0.064% for topical use Initial U.S. Approval: 2006 | prescription | Human Prescription | Leo Pharma Inc. | manufacture | 2015-10-29 | 2 | 502220302 |