GRAVITI PHARMS FDA Approval ANDA 213486

ANDA 213486

GRAVITI PHARMS

FDA Drug Application

Application #213486

Application Sponsors

ANDA 213486GRAVITI PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
002CAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-03-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GRAVITI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213486
            [companyName] => GRAVITI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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