ANDA 200529

CHARTWELL RX

FDA Drug Application

Application #200529

Application Sponsors

ANDA 200529

CHARTWELL RX

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

75MG

0

INDOMETHACIN

INDOMETHACIN

FDA Submissions

	ORIG	1	AP	2010-11-30
LABELING; Labeling	SUPPL	2	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-05-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200529
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-05-09
        )

)