Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016909
Company: ALVOGEN

Products on NDA 16909

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LIDEX	FLUOCINONIDE	0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 016909

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2016	SUPPL-53	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf