ANDA 090403

CADILA

FDA Drug Application

Application #090403

Application Sponsors

ANDA 090403

CADILA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	25MG	0	INDOMETHACIN	INDOMETHACIN
002	CAPSULE;ORAL	50MG	0	INDOMETHACIN	INDOMETHACIN

FDA Submissions

	ORIG	1	AP	2010-11-15
LABELING; Labeling	SUPPL	3	AP	2019-09-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90403
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)