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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022013
Company: MYLAN

Products on NDA 022013

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLUX E	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022013

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

Labels for NDA 022013

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

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