RICONPHARMA LLC FDA Approval ANDA 216404

ANDA 216404

RICONPHARMA LLC

FDA Drug Application

Application #216404

Application Sponsors

ANDA 216404RICONPHARMA LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-12-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RICONPHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216404
            [companyName] => RICONPHARMA LLC
            [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":"12\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-02
        )

)

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