Azelate Topical Foam
- Brand(s)
- Finacea
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Bayer Healthcare Pharmaceuticals Inc. (2015-07-29)
- Oldest Current Product
- 2015-08-03
- License(s)
- NDA
- RxNORM
- TOPICAL FOAM\AZELATE
- FDAOB
- TOPICAL\AEROSOL, FOAM\AZELAIC ACID
- SPL Active
- TOPICAL\AEROSOL, FOAM\AZELAIC ACID
- SPL Moiety
- TOPICAL\AEROSOL, FOAM\AZELAIC ACID
product(s) by strength(s)
azelaic acid 150 mg/ml topical foam
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 504190829 | Finacea | NDA | Bayer Healthcare Pharmaceuticals Inc. | 2015-08-03 | AZELAIC ACID | TOPICAL | AEROSOL, FOAM | NDA207071 | d3f44051-9a13-4bcf-9783-f09286d86f4f |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA207071 | FINACEA | BAYER HEALTHCARE PHARMACEUTICALS INC | 2015-07-29 | p8900554, SUBSTANCE p8435498, TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA p8722021, SUBSTANCE p6730288, SUBSTANCE p7700076, SUBSTANCE | NEW PRODUCT [2018-07-29] | NDA207071_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA207071_001 | RX | AZELAIC ACID (15%) | TOPICAL | AEROSOL, FOAM | True | 2015-07-29 | FINACEA |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6730288 (view patent) | 2019-09-08 | NDA207071, NDA021978, NDA022013 | Desonide Topical Foam Clobetasol Topical Foam |
| 2 | p7700076 (view patent) | 2027-09-18 | NDA207071 | |
| 3 | p8435498 (view patent) | 2024-03-01 | NDA207071 | |
| 4 | p8722021 (view patent) | 2023-10-24 | NDA207071 | |
| 5 | p8900554 (view patent) | 2023-10-24 | NDA207071 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | d3f44051-9a13-4bcf-9783-f09286d86f4f (view SPL) | These highlights do not include all the information needed to use FINACEA FOAM safely and effectively. See full prescribing information for FINACEA FOAM.FINACEA (azelaic acid) Foam, 15% for topical useInitial U.S. Approval: 2015 | prescription | Human Prescription | Bayer Healthcare Pharmaceuticals Inc. | MANUFACTURE | 2015-07-29 | 3 | 504190829 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII