SUVEN PHARMS FDA Approval ANDA 214756

ANDA 214756

SUVEN PHARMS

FDA Drug Application

Application #214756

Application Sponsors

ANDA 214756SUVEN PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-03STANDARD
LABELING; LabelingSUPPL2AP2022-05-03STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAA

CDER Filings

SUVEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214756
            [companyName] => SUVEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOROQUINE PHOSPHATE","activeIngredients":"CHLOROQUINE PHOSPHATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-03
        )

)

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