Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017760
Company: ALLERGAN

Products on NDA 17760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FML	FLUOROMETHOLONE	0.1%	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No

Labels for NDA 017760

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2013	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf
07/13/2001	SUPPL-9	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf