ANDA 216557

AUROBINDO PHARMA

FDA Drug Application

Application #216557

Application Sponsors

ANDA 216557

AUROBINDO PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
002	TABLET, EXTENDED RELEASE;ORAL	60MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
003	TABLET, EXTENDED RELEASE;ORAL	120MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AUROBINDO PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216557
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-07
        )

)