Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022013
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLUX E CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription AB2 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
01/12/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022013_oluxe_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022013s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022013Orig1s013ltr.pdf
04/21/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022013s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022013Orig1s009ltr.pdf
11/10/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022013s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022013s005ltr.pdf
07/17/2007 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/14/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022013s013lbl.pdf
04/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022013s009lbl.pdf
11/10/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022013s005lbl.pdf
01/12/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022013lbl.pdf

OLUX E

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB2

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 AB2 211450 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB2 201402 PERRIGO UK FINCO
OLUX E CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription Yes AB2 022013 MYLAN

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