Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021199
Company: SANTEN
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QUIXIN | LEVOFLOXACIN | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |