NDA 207963

HIKMA

FDA Drug Application

Application #207963

Documents

• Label: 2016-08-23
• Letter: 2016-08-22
• Review: 2016-12-09
• Summary Review: 2016-12-09

Application Sponsors

NDA 207963

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)

0

PALONOSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-08-22

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207963
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.25MG BASE\/2ML (EQ 0.125MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/22\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207963s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/22\/2016","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\\\/2016\\\/207963s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207963Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207963Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207963Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-08-22
        )

)