Application 021265
- Type
- NDA
- Sponsor
- SANDOZ CANADA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INFUVITE PEDIATRIC | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 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 | Yes | Yes |
| 002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN K | 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 | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021265-001 | INFUVITE PEDIATRIC | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 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 | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-02-21 |
| N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 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 | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2004-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021265-001 | AP |
| N021265-002 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021265-001 | INFUVITE PEDIATRIC | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2001-02-21 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021265-002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | 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 | INJECTABLE / INTRAVENOUS | RLD, RS | 2004-01-29 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021265-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021265-002 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N021265-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021265-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021265-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021265-002 | AP | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021265-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021265-002 | AP | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pediatric Infuvite Multiple Vitamins | ASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMIN | Sandoz Inc | 4ff223f7-e076-4e81-8151-5c06724fabd9 | 2025-08-18 | Warnings, Adverse reactions | 021265 NDA021265 54643-9023 |
| Infuvite Pediatric | MULTIPLE VITAMINS INJECTION | Sandoz Inc | 6d06546e-8b0a-4490-82d9-397bd902a044 | 2024-11-20 | Warnings, Adverse reactions | 021265 NDA021265 54643-5646 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54643-5646 | Pediatric Infuvite Multiple Vitamins for Infusion | Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Fo | Sandoz Canada Inc | NDA | Current |
| 54643-5646 | PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION | ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-5646 | PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION | ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-5646 | PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION | ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin | Sandoz Manufacturing Inc | NDA | Current |
| 54643-7886 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-7886 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-7886 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-7886 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Manufacturing Inc | NDA | Current |
| 54643-9023 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-9023 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-9023 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Inc | NDA | Current |
| 54643-9023 | Pediatric Infuvite Multiple Vitamins | Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin | Sandoz Manufacturing Inc | NDA | Current |