DR REDDYS LABS LTD FDA Approval ANDA 204068

ANDA 204068

DR REDDYS LABS LTD

FDA Drug Application

Application #204068

Documents

Letter2016-07-20

Application Sponsors

ANDA 204068DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL20MG;1.1GM0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE
002CAPSULE;ORAL40MG;1.1GM0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2016-07-15

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204068
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204068Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-15
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.