GRAVITI PHARMS FDA Approval ANDA 216629

ANDA 216629

GRAVITI PHARMS

FDA Drug Application

Application #216629

Application Sponsors

ANDA 216629GRAVITI PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL20MG0FUROSEMIDEFUROSEMIDE
002TABLET;ORAL40MG0FUROSEMIDEFUROSEMIDE
003TABLET;ORAL80MG0FUROSEMIDEFUROSEMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

GRAVITI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216629
            [companyName] => GRAVITI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-17
        )

)

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