Application 021163

Type: NDA
Sponsor: SANDOZ CANADA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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	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	Yes	Yes
002	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	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	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021163-001	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	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	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-05-18
N021163-002	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	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	SOLUTION / INTRAVENOUS	AP	RLD, RS	2003-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021163-001	AP
N021163-002	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.

Product history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021163-001	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2000-05-18	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021163-002	INFUVITE ADULT	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	SOLUTION / INTRAVENOUS	RLD, RS	2003-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021163-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021163-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021163-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021163-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021163-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021163-002	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021163-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021163-002	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Infuvite Adult	MULTIPLE VITAMINS INJECTION	Sandoz Inc	14c7bfc5-07e8-400f-b8ff-5e4794dd2805	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021163 application number: NDA021163 ndc (product): 54643-5649

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54643-5649	Infuvite Adult 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
54643-5649	Infuvite Adult 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
54643-5649	Infuvite Adult 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
54643-5649	Infuvite Adult 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
54643-7862	Adult 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
54643-7862	Adult 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
54643-7862	Adult 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
54643-7862	Adult 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
54643-9007	Adult 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
54643-9007	Adult 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
54643-9007	Adult 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
54643-9007	Adult 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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80177	SUPPL	2025-02-04
80180	SUPPL	2024-11-07
36251	SUPPL	2016-03-22
26950	SUPPL	2008-12-11
14540	SUPPL	2004-09-17
4512	SUPPL	2004-09-17
26949	SUPPL	2004-06-07
21483	ORIG	2004-03-28
26948	ORIG	2000-05-18
14539	ORIG	2000-05-18