Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | POWDER;INTRAVENOUS | EQ 1.2GM BASE/VIAL | 1 | KIMYRSA | ORITAVANCIN DIPHOSPHATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-03-12 | STANDARD |
Submissions Property Types
CDER Filings
MELINTA THERAP
cder:Array
(
[0] => Array
(
[ApplNo] => 214155
[companyName] => MELINTA THERAP
[docInserts] => ["",""]
[products] => [{"drugName":"KIMYRSA","activeIngredients":"ORITAVANCIN","strength":"1200MG","dosageForm":"POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/12\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214155s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/12\/2021","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\\\/2021\\\/214155s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214155Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-03-12
)
)