Treats Community Acquired Pneumonia caused by susceptible isolates of Streptococcus…. NDA 205572, held by Fresenius Kabi USA. Moxifloxacin Hydrochloride.
As of Nov 14, 2026, NDA 205572 (Moxifloxacin Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Apr 3, 2015, with 6 approved supplements and 0 published complete response letters.
Moxifloxacin injection is a fluoroquinolone antibacterial drug indicated for treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria. ( 1, 12.4 ) Community Acquired Pneumonia Skin and Skin Structure Infections: Uncomplicated and Complicated Complicated Intra-Abdominal Infections Acute Bacterial Sinusitis Acute Bacterial Exacerbation of Chronic Bronchitis 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Moxifloxacin HydrochlorideEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) · solution;intravenous | Moxifloxacin Hydrochloride | RxReference drug |
| Mar 27, 2020 | Supplement 7Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Mar 5, 2019 | Supplement 5Manufacturing | Approved | |
| Oct 18, 2018 | Supplement 4Labeling · Standard review | Approved | |
| Jul 26, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Mar 24, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 3, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
