UNIQUE PHARM LABS FDA Approval ANDA 212285

ANDA 212285

UNIQUE PHARM LABS

FDA Drug Application

Application #212285

Application Sponsors

ANDA 212285UNIQUE PHARM LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-08-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNIQUE PHARM LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212285
            [companyName] => UNIQUE PHARM LABS
            [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\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)

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