Home Applications 019531 Application 019531
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUTRILIPID 10% SOYBEAN OIL INJECTABLE;INJECTION 10% Yes Yes 002 NUTRILIPID 20% SOYBEAN OIL INJECTABLE;INJECTION 20% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019531-001 NUTRILIPID 10% SOYBEAN OIL 10% INJECTABLE / INJECTION RLD 1993-05-28 N019531-002 NUTRILIPID 20% SOYBEAN OIL 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019531-002 AP
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0264-4460 NutriLipid I.V. Fat Emulsion Soybean Oil B. Braun Medical Inc. NDA Current 0264-4460 NutriLipid I.V. Fat Emulsion Soybean Oil B. Braun Medical Inc. NDA Current 0264-4460 NutriLipid I.V. Fat Emulsion Soybean Oil B. Braun Medical Inc. NDA Current 0264-4460 NutriLipid I.V. Fat Emulsion Soybean Oil B. Braun Medical Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82959 SUPPL 2025-07-28 82958 SUPPL 2025-07-28 82938 SUPPL 2025-07-25 82937 SUPPL 2025-07-25 74299 SUPPL 2023-05-18 74298 SUPPL 2023-05-18 74280 SUPPL 2023-05-18 63954 SUPPL 2020-07-17 63944 SUPPL 2020-07-16 33776 SUPPL 2014-12-05