Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021199
Company: SANTEN
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QUIXIN LEVOFLOXACIN 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
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.cfm
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English