ANDA 201533

DR REDDYS LABS LTD

FDA Drug Application

Application #201533

Documents

• Letter: 2016-04-22
• Letter: 2011-11-21

Application Sponsors

ANDA 201533

DR REDDYS LABS LTD

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

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

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2016-04-21

Submissions Property Types

ORIG

1

Null

42

TE Codes

002

Prescription

AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201533
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.075MG BASE\/1.5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"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":"04\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201533Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201533s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-24
        )

)