FDA.reportPublic FDA data

Application 017673

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOSYN 5%AMINO ACIDSINJECTABLE;INJECTION5% (5GM/100ML)NoNo
002AMINOSYN 7%AMINO ACIDSINJECTABLE;INJECTION7% (7GM/100ML)NoNo
003AMINOSYN 10%AMINO ACIDSINJECTABLE;INJECTION10% (10GM/100ML)NoNo
004AMINOSYN 8.5%AMINO ACIDSINJECTABLE;INJECTION8.5% (8.5GM/100ML)NoNo
005AMINOSYN 8.5% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION8.5%;102MG/100ML;522MG/100ML;410MG/100MLNoNo
006AMINOSYN 7% (PH6)AMINO ACIDSINJECTABLE;INJECTION7% (7GM/100ML)NoNo
007AMINOSYN 8.5% (PH6)AMINO ACIDSINJECTABLE;INJECTION8.5% (8.5GM/100ML)NoNo
008AMINOSYN 10% (PH6)AMINO ACIDSINJECTABLE;INJECTION10% (10GM/100ML)NoNo
009AMINOSYN 8.5% W/ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASICINJECTABLE;INJECTION8.5%;102MG/100ML;487MG/100ML;28MG/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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017673-001AMINOSYN 5%AMINO ACIDS5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-002AMINOSYN 7%AMINO ACIDS7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-003AMINOSYN 10%AMINO ACIDS10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-004AMINOSYN 8.5%AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-005AMINOSYN 8.5% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982
N017673-006AMINOSYN 7% (PH6)AMINO ACIDS7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-007AMINOSYN 8.5% (PH6)AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-008AMINOSYN 10% (PH6)AMINO ACIDS10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-009AMINOSYN 8.5% W/ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC8.5%;102MG/100ML;487MG/100ML;28MG/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 7 of 10 · 396 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2020-11-12 02:37 UTC2020-11N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-183f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-183f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-183f01610625f2…
2019-12-14 00:12 UTC2019-12N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-253f01610625f2…
2019-09-15 20:21 UTC2019-09N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-186a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-186a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-186a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 19821c564ffb4f44…

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4187AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent
0409-4191AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent
0409-4192Aminosyn Sulfite FreeISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent
0409-4203AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13879SUPPL2004-05-27
13880SUPPL2004-03-16
679SUPPL2003-06-22
680SUPPL2003-04-15