Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021571
Company: SANTEN

Products on NDA 021571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IQUIX	LEVOFLOXACIN	1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21571_iquix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21571ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/NDA21-271_Iquix.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021571s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021571Orig1s006ltr.pdf

Labels for NDA 021571

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021571s006lbl.pdf
03/01/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21571_iquix_lbl.pdf