FDA.reportPublic FDA data

Application 017957

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEINAMINE 8%AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATEINJECTABLE;INJECTION8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLNoNo
002NOVAMINE 8.5%AMINO ACIDSINJECTABLE;INJECTION8.5% (8.5GM/100ML)NoNo
003NOVAMINE 11.4%AMINO ACIDSINJECTABLE;INJECTION11.4% (11.4GM/100ML)NoNo
004NOVAMINE 15%AMINO ACIDSINJECTABLE;INJECTION15% (75GM/500ML)NoNo

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
N017957-001VEINAMINE 8%AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982
N017957-002NOVAMINE 8.5%AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09
N017957-003NOVAMINE 11.4%AMINO ACIDS11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09
N017957-004NOVAMINE 15%AMINO ACIDS15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28

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 22:38:342026-08N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-0984e616aacf4f…
2026-09-14 22:38:342026-08N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-0984e616aacf4f…
2026-09-14 22:38:342026-08N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-2884e616aacf4f…
2026-08-18 06:07:402026-07N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-285bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
757SUPPL2005-01-13
756SUPPL2003-05-29