ANDA 210375

DR REDDYS LABS LTD

FDA Drug Application

Application #210375

Documents

• Letter: 2018-01-26

Application Sponsors

ANDA 210375

DR REDDYS LABS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2018-04-17	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210375
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210375Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/17\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/21\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-21
        )

)