ANDA 079175

AVANTHI INC

FDA Drug Application

Application #079175

Application Sponsors

ANDA 079175

AVANTHI INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

75MG

0

INDOMETHACIN

INDOMETHACIN

FDA Submissions

	ORIG	1	AP	2009-03-06
LABELING; Labeling	SUPPL	7	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-05-12	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	13	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AVANTHI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79175
            [companyName] => AVANTHI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"75MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)