Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018309
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT LP DESOXIMETASONE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None Yes No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
03/28/1980 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-19 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/26/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf
11/08/1988 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/23/1986 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/01/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1982 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1981 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/06/1982 SUPPL-2 Labeling

Label is not available on this site.

08/06/1980 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
04/27/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf

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