Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021142
Company: QUAGEN
Company: QUAGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLUX | CLOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM;TOPICAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021142s022lbl.pdf | |
| 04/23/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf | |
| 12/29/2003 | SUPPL-10 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf |
| 10/31/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf | |
| 12/20/2002 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-004_Olux_lbl.pdf | |
| 05/26/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21142lbl.pdf |