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 44.

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	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	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	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	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	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	`a50c72e98297…`

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