ALEMBIC PHARMS LTD FDA Approval ANDA 211822

ANDA 211822

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211822

Application Sponsors

ANDA 211822ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL25MG0CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE
002CAPSULE;ORAL50MG0CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE
003CAPSULE;ORAL75MG0CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211822
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-04
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.