ANDA 202572

WATSON LABS INC

FDA Drug Application

Application #202572

Application Sponsors

ANDA 202572

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

75MG

0

INDOMETHACIN

INDOMETHACIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-12-09
LABELING; Labeling	SUPPL	3	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202572
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-05-09
        )

)