Application 021142
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLUX | CLOBETASOL PROPIONATE | AEROSOL, FOAM;TOPICAL | 0.05% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8167 | clobetasol propionate | clobetasol propionate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8182 | OLUX | clobetasol propionate | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8182 | OLUX | clobetasol propionate | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8182 | OLUX | clobetasol propionate | Mylan Pharmaceuticals Inc | NDA | Current |
| 40076-031 | OLUX | clobetasol propionate | Prestium Pharma, Inc. | NDA | Current |
| 40076-031 | OLUX | clobetasol propionate | Prestium Pharma, Inc. | NDA | Current |
| 40085-888 | Clobetasol Propionate | clobetasol propionate | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53871 | SUPPL | 2018-04-27 |
| 53818 | SUPPL | 2018-04-26 |
| 14486 | SUPPL | 2014-04-25 |
| 4450 | SUPPL | 2014-04-24 |
| 26892 | SUPPL | 2006-07-21 |
| 21472 | ORIG | 2004-03-28 |
| 26891 | SUPPL | 2004-01-02 |
| 14485 | SUPPL | 2004-01-02 |
| 14484 | SUPPL | 2003-12-02 |
| 26890 | SUPPL | 2003-11-25 |
| 4449 | SUPPL | 2003-07-28 |
| 14483 | SUPPL | 2003-04-07 |
| 4448 | SUPPL | 2002-12-20 |
| 26889 | SUPPL | 2002-03-29 |
| 36205 | ORIG | 2000-05-26 |
| 4447 | ORIG | 2000-05-26 |