ANDA 206962

NOVAST LABS

FDA Drug Application

Application #206962

Application Sponsors

ANDA 206962

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 4MG BASE/VIAL

0

TOPOTECAN HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206962
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-30
        )

)