ANDA 206419

HETERO LABS LTD III

FDA Drug Application

Application #206419

Application Sponsors

ANDA 206419

HETERO LABS LTD III

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	2MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
002	CAPSULE, EXTENDED RELEASE;ORAL	4MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206419
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"4MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-12
        )

)