Documents
Application Sponsors
| NDA 205572 | FRESENIUS KABI USA | |
Marketing Status
Application Products
| 001 | SOLUTION;INTRAVENOUS | EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) | 1 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-07-26 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2019-03-05 | N/A |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-03-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 205572
[companyName] => FRESENIUS KABI USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/205572s007lbl.pdf#page=49"]
[products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 400MG BASE\/250ML (EQ 1.6MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205572s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205572s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205572s002lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/03\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205572s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/03\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205572s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205572Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205572Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205572Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205572s007lbl.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205572s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205572Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2019","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Manufacturing Process","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205572Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205572Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/26\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205572s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205572Orig1s002ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"03\/24\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-27
)
)