ALEMBIC PHARMS LTD FDA Approval ANDA 213075

ANDA 213075

ALEMBIC PHARMS LTD

FDA Drug Application

Application #213075

Application Sponsors

ANDA 213075ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 75MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
002TABLET, DELAYED RELEASE;ORALEQ 100MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
003TABLET, DELAYED RELEASE;ORALEQ 150MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE
004TABLET, DELAYED RELEASE;ORALEQ 200MG BASE0DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN; ORIG1AP2022-01-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213075
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 75MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-03
        )

)

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