Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018702
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACLOVATE ALCLOMETASONE DIPROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No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
12/14/1982 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
04/05/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf
07/26/2002 SUPPL-8 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf
04/02/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf
06/22/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1996 SUPPL-5 Labeling

Label is not available on this site.

06/07/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/16/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1983 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
04/05/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf
04/02/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf
07/26/2002 SUPPL-8 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf

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