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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021142
Company: PHARMOBEDIENT

Products on NDA 021142

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OLUX	CLOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021142

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.html

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.

Labels for NDA 021142

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

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