Application 019682

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INJECTABLE;INJECTION	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	No	No
002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INJECTABLE;INJECTION	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	No	No
003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	INJECTABLE;INJECTION	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01
N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01
N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019682-003	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML	INJECTABLE / INJECTION	1988-11-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019682-001	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019682-002	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	INJECTABLE / INJECTION	1988-11-01	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1507	SUPPL	2004-05-27
1506	SUPPL	2004-05-27
1505	SUPPL	2004-05-27