ANDA 210179

NAVINTA LLC

FDA Drug Application

Application #210179

Documents

• Letter: 2018-10-15

Application Sponsors

ANDA 210179

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/VIAL

0

CARMUSTINE

CARMUSTINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210179
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARMUSTINE","activeIngredients":"CARMUSTINE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210179Orig1s000Ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-11
        )

)