MYLAN FDA Approval ANDA 208942

ANDA 208942

MYLAN

FDA Drug Application

Application #208942

Application Sponsors

ANDA 208942MYLAN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 50MG BASE0DOXYCYCLINEDOXYCYCLINE
002CAPSULE;ORALEQ 75MG BASE0DOXYCYCLINEDOXYCYCLINE
003CAPSULE;ORALEQ 100MG BASE0DOXYCYCLINEDOXYCYCLINE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208942
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)

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