Home Applications 018804 Application 018804
Type NDA
Sponsor ABBOTT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMINOSYN 3.5% IN PLASTIC CONTAINER AMINO ACIDS INJECTABLE;INJECTION 3.5% (3.5GM/100ML) No No 002 AMINOSYN 3.5% M IN PLASTIC CONTAINER AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018804-001 AMINOSYN 3.5% IN PLASTIC CONTAINER AMINO ACIDS 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1984-05-15 N018804-002 AMINOSYN 3.5% M IN PLASTIC CONTAINER AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML INJECTABLE / INJECTION 1984-05-15
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N018804-001 AMINOSYN 3.5% IN PLASTIC CONTAINER 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1984-05-15 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018804-002 AMINOSYN 3.5% M IN PLASTIC CONTAINER 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML INJECTABLE / INJECTION 1984-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018804-001 AMINOSYN 3.5% IN PLASTIC CONTAINER 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1984-05-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018804-002 AMINOSYN 3.5% M IN PLASTIC CONTAINER 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML INJECTABLE / INJECTION 1984-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018804-001 AMINOSYN 3.5% IN PLASTIC CONTAINER 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1984-05-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018804-002 AMINOSYN 3.5% M IN PLASTIC CONTAINER 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML INJECTABLE / INJECTION 1984-05-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018804-001 AMINOSYN 3.5% IN PLASTIC CONTAINER 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1984-05-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018804-002 AMINOSYN 3.5% M IN PLASTIC CONTAINER 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML INJECTABLE / INJECTION 1984-05-15 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.