Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019117
Company: TARO

Products on NDA 019117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE	FLUOCINONIDE	0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/1984	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2015	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
10/27/2014	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/05/2015	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
07/01/2003	SUPPL-18	Labeling		Label is not available on this site.
05/09/2001	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/14/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/09/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/19/1991	SUPPL-8	Labeling		Label is not available on this site.
11/04/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/30/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/30/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/12/1989	SUPPL-4	Labeling		Label is not available on this site.
03/08/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.