Application Sponsors
ANDA 206077 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS | 500MG/VIAL | 0 | DAPTOMYCIN | DAPTOMYCIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 206077
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-04-11
)
)