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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050818
Company: HARROW EYE

Summary Review

Products on NDA 050818

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRADEX ST	DEXAMETHASONE; TOBRAMYCIN	0.05%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050818

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2009	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/2009/050818lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050818s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818_tobradex_st_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050818s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf
08/16/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf
08/16/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050818Orig1s007, s008, s009ltr.pdf
08/03/2010	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf

Labels for NDA 050818

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf
08/16/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf
08/16/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050818s007s008s009lbl.pdf
08/03/2010	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050818s001lbl.pdf
02/13/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050818lbl.pdf

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