DR REDDYS LABS LTD FDA Approval ANDA 202194

ANDA 202194

DR REDDYS LABS LTD

FDA Drug Application

Application #202194

Documents

Letter2012-05-22
Review2014-01-17

Application Sponsors

ANDA 202194DR REDDYS LABS LTD

Marketing Status

Over-the-counter001

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

N/A; Not ApplicableORIG1AP2012-05-18
LABELING; LabelingSUPPL2AP2013-07-18STANDARD
LABELING; LabelingSUPPL6AP2020-10-07STANDARD
LABELING; LabelingSUPPL7AP2020-10-07STANDARD
LABELING; LabelingSUPPL8AP2020-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2022-04-12UNKNOWN

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15
SUPPL11Null7

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202194
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202194s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202194Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/18\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2013-07-18
        )

)

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