INTL MEDICATION FDA Approval ANDA 076020

ANDA 076020

INTL MEDICATION

FDA Drug Application

Application #076020

Application Sponsors

ANDA 076020INTL MEDICATION

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 5MG BASE/ML0MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE

FDA Submissions

ORIG1AP2004-07-16
LABELING; LabelingSUPPL2AP2017-04-27STANDARD
LABELING; LabelingSUPPL3AP2017-08-17STANDARD

Submissions Property Types

SUPPL1Null15
SUPPL2Null15
SUPPL3Null7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76020
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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