ANDA 210689

LUPIN LTD

FDA Drug Application

Application #210689

Application Sponsors

ANDA 210689

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 150MG BASE/VIAL

0

FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210689
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-05
        )

)