ANDA 211099

GLAND PHARMA LTD

FDA Drug Application

Application #211099

Application Sponsors

ANDA 211099

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

200MG/VIAL

0

VORICONAZOLE

VORICONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-03-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-06-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-06-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-06-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-06-06	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-12-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211099
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-31
        )

)