Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200738
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTEMAX LOTEPREDNOL ETABONATE 0.5% OINTMENT;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
04/15/2011 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/2011/200738s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200738s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738_lotemax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/15/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200738s000lbl.pdf

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