Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018763
Company: TARO

Products on NDA 018763

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPICORT	DESOXIMETASONE	0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018763

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/1983	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
02/18/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/25/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/19/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/13/1993	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/2004	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18763slr003ltr.pdf
02/18/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018763

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2004	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf