ANDA 201807

HETERO LABS LTD III

FDA Drug Application

Application #201807

Application Sponsors

ANDA 201807

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

75MG

0

INDOMETHACIN

INDOMETHACIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-09-28
LABELING; Labeling	SUPPL	5	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201807
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-05-09
        )

)