FDA.reportPublic FDA data

Application 019712

Type
NDA
Sponsor
ABBOTT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLNoNo
002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08
N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-0884e616aacf4f…
2026-09-14 22:38:342026-08N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-0884e616aacf4f…
2026-08-18 06:07:402026-07N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019712-001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLINJECTABLE / INJECTION1988-09-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019712-002AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLINJECTABLE / INJECTION1988-09-0874a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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