Documents
Application Sponsors
| NDA 021265 | SANDOZ CANADA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | 1 | INFUVITE PEDIATRIC | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K |
| 002 | INJECTABLE;INTRAVENOUS | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | 1 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN K |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2001-02-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-02-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2006-08-22 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2008-12-17 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2014-09-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2014-11-11 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2016-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 13 | Null | 31 |
| SUPPL | 15 | Null | 4 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 0 |
CDER Filings
SANDOZ CANADA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21265
[companyName] => SANDOZ CANADA INC
[docInserts] => ["",""]
[products] => [{"drugName":"INFUVITE PEDIATRIC","activeIngredients":"ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K","strength":"80MG\/VIAL;0.02MG\/VIAL;400 IU\/VIAL;0.001MG\/VIAL;5MG\/VIAL;0.14MG\/VIAL;17MG\/VIAL;1MG\/VIAL;1.4MG\/VIAL;1.2MG\/VIAL;7 IU\/VIAL;2,300 IU\/VIAL;0.2MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)","activeIngredients":"ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN K","strength":"80MG\/VIAL;0.02MG\/VIAL;400 IU\/VIAL;0.001MG\/VIAL;5MG\/VIAL;0.14MG\/VIAL;17MG\/VIAL;1MG\/VIAL;1.4MG\/VIAL;1.2MG\/VIAL;7 IU\/VIAL;2,300 IU\/VIAL;0.2MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/17\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021265s030,021646s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2008","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021265s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2008","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021265s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2001","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21265s1lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-265_Infuvite%20Pediatric_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"INFUVITE PEDIATRIC","submission":"ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K","actionType":"80MG\/VIAL;0.02MG\/VIAL;400 IU\/VIAL;0.001MG\/VIAL;5MG\/VIAL;0.14MG\/VIAL;17MG\/VIAL;1MG\/VIAL;1.4MG\/VIAL;1.2MG\/VIAL;7 IU\/VIAL;2,300 IU\/VIAL;0.2MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)","submission":"ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN K","actionType":"80MG\/VIAL;0.02MG\/VIAL;400 IU\/VIAL;0.001MG\/VIAL;5MG\/VIAL;0.14MG\/VIAL;17MG\/VIAL;1MG\/VIAL;1.4MG\/VIAL;1.2MG\/VIAL;7 IU\/VIAL;2,300 IU\/VIAL;0.2MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-03-17
)
)