Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021571
Company: SANTEN
Company: SANTEN
| 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| IQUIX | LEVOFLOXACIN | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |
| 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 |