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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021565
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELESTAT EPINASTINE HYDROCHLORIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
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
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