NDA 203050

DR REDDYS LABS LTD

FDA Drug Application

Application #203050

Documents

• Letter: 2012-11-06
• Letter: 2016-03-03
• Label: 2016-03-03
• Review: 2016-12-13

Application Sponsors

NDA 203050

DR REDDYS LABS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-03-01

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

DR REDDYS LABS LTD

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(
    [0] => Array
        (
            [ApplNo] => 203050
            [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":"SOLUTION;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":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/01\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203050s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/01\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203050s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203050Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203050Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203050Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-03-01
        )

)