ANDA 208997

NOVAST LABS

FDA Drug Application

Application #208997

Application Sponsors

ANDA 208997

NOVAST LABS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10MG BASE/ML

0

VINORELBINE TARTRATE

VINORELBINE TARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208997
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VINORELBINE TARTRATE","activeIngredients":"VINORELBINE TARTRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-20
        )

)