ALEMBIC PHARMS LTD FDA Approval ANDA 210537

ANDA 210537

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210537

Application Sponsors

ANDA 210537ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 20MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-03-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210537
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-04
        )

)

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