EPIC PHARMA LLC FDA Approval ANDA 214207

ANDA 214207

EPIC PHARMA LLC

FDA Drug Application

Application #214207

Application Sponsors

ANDA 214207EPIC PHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 75MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
002TABLET;ORALEQ 150MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EPIC PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214207
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)

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