MYLAN FDA Approval ANDA 209987

ANDA 209987

MYLAN

FDA Drug Application

Application #209987

Application Sponsors

ANDA 209987MYLAN

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-10-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209987
            [companyName] => MYLAN
            [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":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.