Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050804
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYLET LOTEPREDNOL ETABONATE; TOBRAMYCIN 0.5%;0.3% SUSPENSION/DROPS;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
12/14/2004 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050804ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50804_ZyletTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050804Orig1s018ltr.pdf
10/02/2012 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050804Orig1s017ltr.pdf
06/03/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050804s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050804s015ltr.pdf
08/07/2006 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2013 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050804s018lbl.pdf
10/02/2012 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050804s017lbl.pdf
06/03/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050804s015lbl.pdf
12/14/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050804lbl.pdf

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