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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022288s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022288s000_SumR.pdf
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022288Orig1s008ltr.pdf
02/05/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/28/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022288s003ltr.pdf
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

BEPREVE

SOLUTION/DROPS;OPHTHALMIC; 1.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206066 APOTEX
BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206220 MYLAN
BEPREVE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 022288 BAUSCH AND LOMB INC
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