ANDA 206398

ALVOGEN

FDA Drug Application

Application #206398

Application Sponsors

ANDA 206398

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

200MG/VIAL

0

VORICONAZOLE

VORICONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-07-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206398
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-23
        )

)