ANDA 090862

SANDOZ INC

FDA Drug Application

Application #090862

Documents

• Review: 2012-09-12

Application Sponsors

ANDA 090862

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

200MG/VIAL

0

VORICONAZOLE

VORICONAZOLE

FDA Submissions

	ORIG	1	AP	2012-05-30
LABELING; Labeling	SUPPL	2	AP	2015-10-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-06-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90862
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VORICONAZOLE","submission":"VORICONAZOLE","actionType":"200MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)