Application 019713

Type: NDA
Sponsor: ABBOTT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;10GM/100ML	No	No
002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	3.5%;5GM/100ML	No	No
003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;25GM/100ML	No	No
004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;20GM/100ML	No	No
005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;25GM/100ML	No	No
006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	3.5%;25GM/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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09
N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09
N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09
N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09
N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09
N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09

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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019713-003	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019713-004	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	4.25%;20GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019713-005	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	4.25%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019713-006	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	3.5%;25GM/100ML	INJECTABLE / INJECTION	1988-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019713-001	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	4.25%;10GM/100ML	INJECTABLE / INJECTION	1988-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019713-002	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	3.5%;5GM/100ML	INJECTABLE / INJECTION	1988-09-09	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

Application 019713

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#