FDA.reportPublic FDA data

Application 019564

Type
NDA
Sponsor
ABBOTT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLNoNo
002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLNoNo
003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLNoNo
004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16
N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16
N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16
N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16

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 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1684e616aacf4f…
2026-08-18 06:07:402026-07N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019564-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019564-002AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019564-003AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1986-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019564-004AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100MLINJECTABLE / INJECTION1986-12-165bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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