Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020841
Company: PHARMOS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTEMAX LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS;OPHTHALMIC Discontinued None No 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
03/09/1998 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20841lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20841ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020841_Lotemax.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20841lbl.pdf

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