Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019958
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUTIVATE FLUTICASONE PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2010 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf
06/07/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/2002 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf
01/21/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/17/1999 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf
08/08/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/25/1997 SUPPL-9 Efficacy-New Patient Population

Label is not available on this site.

06/17/1999 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19958S8_Cutivate.cfm
06/07/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/07/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/07/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf
04/16/2002 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf
06/17/1999 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
06/17/1999 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf

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