ALEMBIC PHARMS LTD FDA Approval ANDA 211744

ANDA 211744

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211744

Application Sponsors

ANDA 211744ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-06-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211744
            [companyName] => ALEMBIC PHARMS LTD
            [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":"06\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-30
        )

)

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