ANDA 213057

ZYDUS

FDA Drug Application

Application #213057

Application Sponsors

ANDA 213057

ZYDUS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	5MG	0	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE
002	TABLET;ORAL	10MG	0	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE
003	TABLET;ORAL	20MG	0	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE
004	TABLET;ORAL	30MG	0	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE
005	TABLET;ORAL	40MG	0	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213057
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-20
        )

)