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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021835
Company: GALDERMA LABS LP

Products on NDA 021835

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021835

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.

Labels for NDA 021835

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

Therapeutic Equivalents for NDA 021835

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	211191	ALEMBIC
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	PADAGIS US
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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