FDA.reportPublic FDA data

Application 019437

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004AMINOSYN II 10% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLNoNo
005AMINOSYN II 8.5% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLNoNo
006AMINOSYN II 7% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLNoNo
007AMINOSYN II 3.5% MAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLNoNo
008AMINOSYN II 8.5% W/ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASICINJECTABLE;INJECTION8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019437-004AMINOSYN II 10% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03
N019437-005AMINOSYN II 8.5% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03
N019437-006AMINOSYN II 7% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03
N019437-007AMINOSYN II 3.5% MAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-03
N019437-008AMINOSYN II 8.5% W/ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25

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 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019437-004AMINOSYN II 10% W/ ELECTROLYTES10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019437-005AMINOSYN II 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019437-006AMINOSYN II 7% W/ ELECTROLYTES7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTION1986-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019437-007AMINOSYN II 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100MLINJECTABLE / INJECTION1986-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019437-008AMINOSYN II 8.5% W/ELECTROLYTES8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-251e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4171Aminosyn II with ElectrolytesISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ALANINE, ARGIHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17404SUPPL2004-05-27
17403SUPPL2003-07-06