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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022428
Company: HARROW EYE

Summary Review

Products on NDA 022428

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOXEZA	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2010	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/2010/022428s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022428s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428_moxeza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022428Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022428s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022428Orig1s010ltr.pdf
02/17/2017	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022428Orig1s009ltr.pdf
09/14/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022428Orig1s002ltr.pdf
10/18/2011	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022428s001ltr.pdf

Labels for NDA 022428

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022428s010lbl.pdf
02/17/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf
02/17/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022428s009lbl.pdf
09/14/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022428s002lbl.pdf
11/19/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022428s000lbl.pdf

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