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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019957
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUTIVATE FLUTICASONE PROPIONATE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT;TOPICAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/19/2021 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf
02/18/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf
01/18/2002 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
12/09/2001 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
12/09/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
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