NDA 212155

ZIONEXA US CORP

FDA Drug Application

Application #212155

Documents

• Label: 2020-05-22
• Letter: 2020-05-22
• Review: 2020-06-19

Application Sponsors

NDA 212155

ZIONEXA US CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

148MBQ/ML TO 3700MBQ/ML(4MCI/ML TO 100MCI/ML)

2

CERIANNA

FLUOROESTRADIOL F18

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-05-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-04-06	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	14	Null	15

CDER Filings

ZIONEXA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212155
            [companyName] => ZIONEXA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CERIANNA","activeIngredients":"FLUOROESTRADIOL F-18","strength":"50ML (4-100mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/20\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212155s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212155s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212155Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/212155Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-20
        )

)