Home Applications 019713 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 TE codes RLD / RS 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 5 of 7 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2020-11-12 02:37 UTC 2020-11 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 a72a2bbeb626…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.