Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021142
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLUX | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/26/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21142lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21142ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-142_Olux.cfm |
Supplements
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021142s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021142Orig1s022ltr.pdf | |
04/23/2014 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021142s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021142Orig1s019ltr.pdf | |
06/07/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/11/2006 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021142s012ltr.pdf |
12/29/2003 | SUPPL-10 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142scs010_olux_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scs010ltr.pdf | |
10/31/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21142slr009_olux_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142slr009ltr.pdf | |
07/21/2003 | SUPPL-7 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21142scm007ltr.pdf |
09/17/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/21/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/20/2002 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21142se1-004_Olux_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142se1-004ltr.pdf | |
03/13/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21142s3ltr.pdf |
11/29/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/14/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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 |