PRAXGEN FDA Approval ANDA 212487

ANDA 212487

PRAXGEN

FDA Drug Application

Application #212487

Application Sponsors

ANDA 212487PRAXGEN

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 100MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-30STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

PRAXGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212487
            [companyName] => PRAXGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)

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