Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202872
Company: BAUSCH AND LOMB INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTEMAX LOTEPREDNOL ETABONATE 0.5% GEL;OPHTHALMIC Prescription None 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
09/28/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202872Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872_lotemax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2018 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202872s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202872Orig1s002Ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/20/2018 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202872s002lbl.pdf
09/28/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf

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