NDA 214155

MELINTA THERAP

FDA Drug Application

Application #214155

Documents

• Letter: 2021-03-16
• Label: 2021-03-16
• Label: 2021-07-26
• Letter: 2021-07-27

Application Sponsors

NDA 214155

MELINTA THERAP

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

ORIG

1

Null

15

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
        )

)