Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021758
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANOS FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription AB 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
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
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

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 PHARMS LLC
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 200735 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 091282 GLENMARK GENERICS
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 090256 PERRIGO ISRAEL
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 200734 TARO
FLUOCINONIDE FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211758 TELIGENT PHARMA INC
VANOS FLUOCINONIDE 0.1% CREAM;TOPICAL Prescription Yes AB 021758 MEDICIS

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