Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205572
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/03/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205572s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205572Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205572Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/27/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf | |
05/03/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205572s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205572Orig1s006ltr.pdf | |
03/05/2019 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205572Orig1s005ltr.pdf |
10/18/2018 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205572s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205572Orig1s004ltr.pdf | |
07/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205572s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205572Orig1s002ltr.pdf |
03/24/2016 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/27/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf | |
05/03/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205572s006lbl.pdf | |
10/18/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205572s004lbl.pdf | |
10/18/2018 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205572s004lbl.pdf | |
07/26/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205572s002lbl.pdf |
04/03/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205572s000lbl.pdf |