Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018586
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL;TOPICAL Discontinued None Yes No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
03/29/1982 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
09/15/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/22/1996 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/26/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18586slr004_topicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18586slr004ltr.pdf
09/25/1991 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1989 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1983 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18586slr004_topicort_lbl.pdf

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