ANDA 203946

ESSENTIAL ISOTOPES

FDA Drug Application

Application #203946

Application Sponsors

ANDA 203946

ESSENTIAL ISOTOPES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

20-300mCi/ML

0

FLUDEOXYGLUCOSE F18

FLUDEOXYGLUCOSE F-18

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-02-05
LABELING; Labeling	SUPPL	3	AP	2020-01-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	31

TE Codes

001

Prescription

AP

CDER Filings

ESSENTIAL ISOTOPES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203946
            [companyName] => ESSENTIAL ISOTOPES
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDEOXYGLUCOSE F18","activeIngredients":"FLUDEOXYGLUCOSE F-18","strength":"20-300mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-03
        )

)