AJANTA PHARMA LTD FDA Approval ANDA 213897

ANDA 213897

AJANTA PHARMA LTD

FDA Drug Application

Application #213897

Application Sponsors

ANDA 213897AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-10-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213897
            [companyName] => AJANTA PHARMA 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":"10\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-02
        )

)

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