Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021565
Company: ALLERGAN

Products on NDA 21565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELESTAT	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Labels for NDA 021565

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2011	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf
08/15/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf
10/16/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf