ANDA 213199

SUNGEN PHARMA

FDA Drug Application

Application #213199

Application Sponsors

ANDA 213199

SUNGEN PHARMA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

EQ 150MG BASE/VIAL

0

FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-07-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

SUNGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213199
            [companyName] => SUNGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)