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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050804
Company: BAUSCH AND LOMB

Products on NDA 050804

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050804

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
10/25/2021	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050804s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050804Orig1s026ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 050804

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2021	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050804s026lbl.pdf
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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