EUGIA PHARMA FDA Approval ANDA 213358

ANDA 213358

EUGIA PHARMA

FDA Drug Application

Application #213358

Application Sponsors

ANDA 213358EUGIA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 10MG BASE0TAMOXIFEN CITRATETAMOXIFEN CITRATE
002TABLET;ORALEQ 20MG BASE0TAMOXIFEN CITRATETAMOXIFEN CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213358
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMOXIFEN CITRATE","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAMOXIFEN CITRATE","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TAMOXIFEN CITRATE","submission":"TAMOXIFEN CITRATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAMOXIFEN CITRATE","submission":"TAMOXIFEN CITRATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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