ALEMBIC PHARMS LTD FDA Approval ANDA 209785

ANDA 209785

ALEMBIC PHARMS LTD

FDA Drug Application

Application #209785

Application Sponsors

ANDA 209785ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL10MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE
002TABLET;ORAL25MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE
003TABLET;ORAL50MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE
004TABLET;ORAL75MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE
005TABLET;ORAL100MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE
006TABLET;ORAL150MG0DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209785
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESIPRAMINE HYDROCHLORIDE","activeIngredients":"DESIPRAMINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-07
        )

)

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