RICONPHARMA LLC FDA Approval ANDA 215586

ANDA 215586

RICONPHARMA LLC

FDA Drug Application

Application #215586

Application Sponsors

ANDA 215586RICONPHARMA LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL37.5MG;20MG0ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

RICONPHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215586
            [companyName] => RICONPHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE","strength":"37.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-06
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.