FDA.reportPublic FDA data

Application 019438

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOSYN II 3.5%AMINO ACIDSINJECTABLE;INJECTION3.5% (3.5GM/100ML)NoNo
002AMINOSYN II 5%AMINO ACIDSINJECTABLE;INJECTION5% (5GM/100ML)NoNo
003AMINOSYN II 7%AMINO ACIDSINJECTABLE;INJECTION7% (7GM/100ML)NoNo
004AMINOSYN II 8.5%AMINO ACIDSINJECTABLE;INJECTION8.5% (8.5GM/100ML)NoNo
005AMINOSYN II 10%AMINO ACIDSINJECTABLE;INJECTION10% (10GM/100ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019438-001AMINOSYN II 3.5%AMINO ACIDS3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-03
N019438-002AMINOSYN II 5%AMINO ACIDS5% (5GM/100ML)INJECTABLE / INJECTION1986-04-03
N019438-003AMINOSYN II 7%AMINO ACIDS7% (7GM/100ML)INJECTABLE / INJECTION1986-04-03
N019438-004AMINOSYN II 8.5%AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-03
N019438-005AMINOSYN II 10%AMINO ACIDS10% (10GM/100ML)INJECTABLE / INJECTION1986-04-03

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019438-001AMINOSYN II 3.5%3.5% (3.5GM/100ML)INJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019438-002AMINOSYN II 5%5% (5GM/100ML)INJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019438-003AMINOSYN II 7%7% (7GM/100ML)INJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019438-004AMINOSYN II 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1986-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019438-005AMINOSYN II 10%10% (10GM/100ML)INJECTABLE / INJECTION1986-04-032680178bc6a6…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4162Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent
0409-4164Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANIHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17405SUPPL2004-05-27