ENSTILAR is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Leo Pharma Inc.. The primary component is Betamethasone Dipropionate; Calcipotriene Monohydrate.
| Product ID | 50222-302_0b771976-2050-4eef-bc39-3c853c7c0ac2 |
| NDC | 50222-302 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ENSTILAR |
| Generic Name | Calcipotriene And Betamethasone Dipropionate |
| Dosage Form | Aerosol, Foam |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2015-10-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA207589 |
| Labeler Name | LEO Pharma Inc. |
| Substance Name | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE |
| Active Ingredient Strength | 1 mg/g; ug/g |
| Pharm Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2015-10-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA207589 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2015-10-16 |
| Marketing Category | NDA |
| Application Number | NDA207589 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-10-16 |
| Marketing Category | NDA |
| Application Number | NDA207589 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2015-10-16 |
| Ingredient | Strength |
|---|---|
| CALCIPOTRIENE HYDRATE | 50 ug/g |
| SPL SET ID: | d1193df2-d53f-4342-bd9d-d9cba7c89709 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50222-302 | ENSTILAR | calcipotriene and betamethasone dipropionate |
| 0781-7165 | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | calcipotriene and betamethasone dipropionate |
| 45802-889 | calcipotriene and betamethasone dipropionate | calcipotriene and betamethasone dipropionate |
| 45802-989 | Calcipotriene and Betamethasone Dipropionate | calcipotriene and betamethasone dipropionate |
| 51672-1402 | Calcipotriene and Betamethasone Dipropionate | Calcipotriene and Betamethasone Dipropionate |
| 63629-8618 | calcipotriene and betamethasone dipropionate | calcipotriene and betamethasone dipropionate |
| 63629-8619 | calcipotriene and betamethasone dipropionate | calcipotriene and betamethasone dipropionate |
| 63646-040 | calcipotriene and betamethasone dipropionate | calcipotriene and betamethasone dipropionate |
| 66993-937 | Calcipotriene and Betamethasone Dipropionate | Calcipotriene and Betamethasone Dipropionate |
| 66993-938 | Calcipotriene and Betamethasone Dipropionate | Calcipotriene and Betamethasone Dipropionate |
| 50222-227 | Taclonex | calcipotriene and betamethasone dipropionate |
| 50222-501 | TACLONEX | calcipotriene and betamethasone dipropionate |
| 73499-001 | Wynzora | Calcipotriene and Betamethasone dipropionate |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENSTILAR 79130021 4541093 Live/Registered |
LEO Pharma A/S 2012-11-20 |