ANDA 205648

QILU

FDA Drug Application

Application #205648

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 205648

QILU

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INTRAVENOUS	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	0	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE
002	INJECTABLE;INTRAVENOUS	EQ 0.075MG BASE/1.5ML (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
002	Prescription	AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205648
            [companyName] => QILU
            [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"},{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.075MG BASE\/1.5ML (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":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205648Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-19
        )

)