ANDA 210701

APOTEX

FDA Drug Application

Application #210701

Application Sponsors

ANDA 210701

APOTEX

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	AMBRISENTAN	AMBRISENTAN
002	TABLET;ORAL	10MG	0	AMBRISENTAN	AMBRISENTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210701
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMBRISENTAN","submission":"AMBRISENTAN","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMBRISENTAN","submission":"AMBRISENTAN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)