NDA 211844

INFORLIFE

FDA Drug Application

Application #211844

Documents

• Label: 2021-03-23
• Letter: 2021-03-24
• Review: 2021-07-12
• Letter: 2021-10-20
• Letter: 2023-01-17
• Label: 2023-01-17

Application Sponsors

NDA 211844

INFORLIFE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	UNKNOWN	UNKNOWN	2	MIDAZOLAM	MIDAZOLAM
002	SOLUTION;INTRAVENOUS	100MG/100ML (1MG/ML)	1	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2021-03-22	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2023-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6

TE Codes

001

Prescription

TBD

CDER Filings

INFORLIFE

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(
    [0] => Array
        (
            [ApplNo] => 211844
            [companyName] => INFORLIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM","activeIngredients":"MIDAZOLAM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211844s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211844s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)