Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021142
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLUX CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription AB1 Yes Yes
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

OLUX

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 210809 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 206805 INGENUS PHARMS LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 077763 PERRIGO ISRAEL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 208779 TARO
OLUX CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription Yes AB1 021142 MYLAN

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