ANDA 204397

HETERO LABS LTD V

FDA Drug Application

Application #204397

Application Sponsors

ANDA 204397

HETERO LABS LTD V

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	1MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
002	TABLET;ORAL	2MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-02

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204397
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-02
        )

)