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 4 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 2019-12-13 00:20 UTC 2019-12 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019713-005 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER 4.25%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019713-006 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER 3.5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019713-001 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER 4.25%;10GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019713-002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER 3.5%;5GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019713-003 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER 5%;25GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019713-004 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER 4.25%;20GM/100ML INJECTABLE / INJECTION 1988-09-09 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.