NDA 21832, held by Sicor Pharms. Levofloxacin; Sodium Chloride.
As of Nov 14, 2026, NDA 21832 (Levofloxacin), held by Sicor Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2005 | Original applicationNew dosage form · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levofloxacin5MG/ML · injectable; injection | Levofloxacin; Sodium Chloride | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
