GRAVITI PHARMS FDA Approval ANDA 216349

ANDA 216349

GRAVITI PHARMS

FDA Drug Application

Application #216349

Application Sponsors

ANDA 216349GRAVITI PHARMS

Marketing Status

Over-the-counter001

Application Products

001CAPSULE, DELAYED RELEASE;ORALEQ 20MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-06-24STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

GRAVITI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216349
            [companyName] => GRAVITI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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