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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206307
Company: FONSECA BIOSCIENCES

Summary Review

Products on NDA 206307

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XTORO	FINAFLOXACIN	0.3%	SUSPENSION/DROPS;OTIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206307

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206307Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2026	SUPPL-6	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/206307Orig1s006ltr.pdf
03/18/2026	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206307s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/206307Orig1s004ltr.pdf
12/29/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206307

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2026	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206307s004lbl.pdf
03/18/2026	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206307s004lbl.pdf
03/18/2026	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206307s004lbl.pdf
12/17/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf

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