UMEDICA LABS PVT LTD FDA Approval ANDA 216594

ANDA 216594

UMEDICA LABS PVT LTD

FDA Drug Application

Application #216594

Application Sponsors

ANDA 216594UMEDICA LABS PVT LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL100MG0CARBAMAZEPINECARBAMAZEPINE
002TABLET, EXTENDED RELEASE;ORAL200MG0CARBAMAZEPINECARBAMAZEPINE
003TABLET, EXTENDED RELEASE;ORAL400MG0CARBAMAZEPINECARBAMAZEPINE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UMEDICA LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216594
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)

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