An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021142
Company: MYLAN

Products on NDA 021142

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

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.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.

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

Top