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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018586
Company: TARO

Products on NDA 018586

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TOPICORT	DESOXIMETASONE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018586

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.

Labels for NDA 018586

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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