NDA 210064

TEVA PHARMS USA

FDA Drug Application

Application #210064

Documents

• Letter: 2019-09-06
• Label: 2019-09-06
• Review: 2020-03-19

Application Sponsors

NDA 210064

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 150MG BASE/VIAL

0

FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-09-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210064
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/05\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210064s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/05\/2019","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\\\/2019\\\/210064s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210064Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210064Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-09-05
        )

)