Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021835
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBEX CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription AT 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
10/27/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021835ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021835s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021835s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021835Orig1s015Ltr.pdf
04/15/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/21/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/17/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s007ltr.pdf
09/07/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s006ltr.pdf
01/12/2011 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf
01/12/2011 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf
02/13/2007 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021835s015lbl.pdf
09/07/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf
08/17/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf
01/12/2011 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf
01/12/2011 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf
01/12/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf
10/27/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf

CLOBEX

SPRAY;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 207218 AKORN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 211191 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 209004 GLENMARK PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 208125 LUPIN LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 090898 PADDOCK LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 208842 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 206378 ZYDUS PHARMS
CLOBEX CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription Yes AT 021835 GALDERMA LABS LP

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