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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021199
Company: SANTEN

Products on NDA 021199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUIXIN	LEVOFLOXACIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No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 021199

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2000	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21199ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-199_Quixin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2014	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021199s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021199Orig1s014ltr.pdf
04/11/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf
04/11/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf
06/04/2002	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s003ltr.pdf
04/18/2002	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s2ltr.pdf
10/10/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021199

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021199s014lbl.pdf
04/11/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf
04/11/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf
06/04/2002	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s003lbl.pdf
04/18/2002	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s2lbl.pdf
08/18/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21199lbl.pdf

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