ANDA 215586

RICONPHARMA LLC

FDA Drug Application

Application #215586

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 215586

RICONPHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

37.5MG;20MG

0

ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)