AJANTA PHARMA LTD FDA Approval ANDA 205545

ANDA 205545

AJANTA PHARMA LTD

FDA Drug Application

Application #205545

Application Sponsors

ANDA 205545AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL20MG/PACKET;1.68GM/PACKET0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE
002FOR SUSPENSION;ORAL40MG/PACKET;1.68GM/PACKET0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2016-07-27STANDARD
LABELING; LabelingSUPPL4AP2020-04-06STANDARD
LABELING; LabelingSUPPL7AP2020-04-06STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null7
SUPPL7Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205545
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG\/PACKET;1.68GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG\/PACKET;1.68GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)

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