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 44.

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017957-001VEINAMINE 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100MLINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017957-002NOVAMINE 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTION1982-08-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017957-003NOVAMINE 11.4%11.4% (11.4GM/100ML)INJECTABLE / INJECTION1982-08-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017957-004NOVAMINE 15%15% (75GM/500ML)INJECTABLE / INJECTION1986-11-284b0b4de00fa7…

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