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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022288
Company: BAUSCH AND LOMB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEPREVE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf
06/28/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf
09/08/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf
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