Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019957
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUTIVATE FLUTICASONE PROPIONATE 0.005% OINTMENT;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
12/14/1990 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/18/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf
01/18/2002 SUPPL-11 Efficacy-New Patient Population 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
06/07/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2001 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
06/30/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/09/2001 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
11/12/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/07/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

06/07/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/07/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1995 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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