ANDA 210822

DEXCEL LTD

FDA Drug Application

Application #210822

Application Sponsors

ANDA 210822

DEXCEL LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

120MG

0

ISOSORBIDE MONONITRATE

ISOSORBIDE MONONITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

DEXCEL LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210822
            [companyName] => DEXCEL LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-29
        )

)