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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021758
Company: BAUSCH

Products on NDA 021758

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANOS	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021758

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021758lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021758s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2016	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/18/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/16/2012	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021758s017ltr.pdf
11/10/2011	SUPPL-16	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021758s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021758s016ltr.pdf
12/30/2010	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s014ltr.pdf
03/08/2010	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021758s012ltr.pdf
12/13/2006	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s007ltr.pdf
03/13/2006	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
11/23/2005	SUPPL-2	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021758s002ltr.pdf
03/02/2006	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s00lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021758s001ltr.pdf

Labels for NDA 021758

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021758s017lbl.pdf
11/10/2011	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021758s016lbl.pdf
12/30/2010	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s014lbl.pdf
03/08/2010	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021758s012lbl.pdf
12/13/2006	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s007lbl.pdf
03/02/2006	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021758s00lbl.pdf
02/11/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021758lbl.pdf

Therapeutic Equivalents for NDA 021758

VANOS

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	211111	AMNEAL
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200735	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	091282	GLENMARK PHARMS LTD
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200734	TARO
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208989	ZYDUS LIFESCIENCES
VANOS	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021758	BAUSCH

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