NDA 021163

SANDOZ CANADA INC

FDA Drug Application

Application #021163

Documents

• Letter: 2004-09-17
• Label: 2000-05-18
• Label: 2004-09-17
• Review: 2004-03-28
• Letter: 2000-05-18
• Letter: 2004-06-07
• Letter: 2008-12-11
• Label: 2016-03-22

Application Sponsors

NDA 021163

SANDOZ CANADA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML	1	INFUVITE ADULT	ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
002	SOLUTION;INTRAVENOUS	2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML	1	INFUVITE ADULT	ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2000-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-07-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-02-12	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2006-08-22	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2008-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2015-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2015-10-26	STANDARD
LABELING; Labeling	SUPPL	32	AP	2016-03-17	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	16	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	15

CDER Filings

SANDOZ CANADA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21163
            [companyName] => SANDOZ CANADA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INFUVITE ADULT","activeIngredients":"ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K","strength":"2 IU\/ML;40MG\/ML;12MCG\/ML;40 IU\/ML;1MCG\/ML;3MG\/ML;120MCG\/ML;8MG\/ML;1.2MG\/ML;0.72MG\/ML;1.2MG\/ML;660 IU\/ML;0.03MG\/ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUVITE ADULT","activeIngredients":"ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K","strength":"2 IU\/ML;40MG\/ML;12MCG\/ML;40 IU\/ML;1MCG\/ML;3MG\/ML;120MCG\/ML;8MG\/ML;1.2MG\/ML;0.72MG\/ML;1.2MG\/ML;660 IU\/ML;30MCG\/ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/17\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021163s032,021559s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21163s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21163lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INFUVITE ADULT","submission":"ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K","actionType":"2 IU\/ML;40MG\/ML;12MCG\/ML;40 IU\/ML;1MCG\/ML;3MG\/ML;120MCG\/ML;8MG\/ML;1.2MG\/ML;0.72MG\/ML;1.2MG\/ML;660 IU\/ML;0.03MG\/ML","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INFUVITE ADULT","submission":"ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K","actionType":"2 IU\/ML;40MG\/ML;12MCG\/ML;40 IU\/ML;1MCG\/ML;3MG\/ML;120MCG\/ML;8MG\/ML;1.2MG\/ML;0.72MG\/ML;1.2MG\/ML;660 IU\/ML;30MCG\/ML","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-03-17
        )

)