Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021664
Company: BAUSCH AND LOMB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROMDAY BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
XIBROM BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/24/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021664ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021664s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/27/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf
01/27/2014 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf
10/16/2010 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021664s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021664Orig1s013.pdf
06/02/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf
01/27/2006 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
01/27/2014 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
10/16/2010 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf
06/02/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf
01/27/2006 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf
03/24/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf

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