ANDA 206396

CIPLA

FDA Drug Application

Application #206396

Application Sponsors

ANDA 206396

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

0

PALONOSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206396
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.25MG BASE\/5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-30
        )

)