Application 207648
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | EMULSION;INTRAVENOUS | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | Yes | Yes |
| 002 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | EMULSION;INTRAVENOUS | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | Yes | Yes |
| 003 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | EMULSION;INTRAVENOUS | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | Yes | Yes |
| 004 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | EMULSION;INTRAVENOUS | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207648-001 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | |
| N207648-002 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | |
| N207648-003 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | |
| N207648-004 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 |
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.
| 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 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207648-001 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207648-002 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207648-003 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | EMULSION / INTRAVENOUS | RLD, RS | 2016-07-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207648-004 | SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | EMULSION / INTRAVENOUS | RLD, RS | 2018-08-10 | d06236e962d9… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207648-001 | NPP | 2025-03-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207648-002 | NPP | 2025-03-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207648-003 | NPP | 2025-03-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207648-004 | NPP | 2025-03-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207648-001 | NPP | 2025-03-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207648-002 | NPP | 2025-03-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207648-003 | NPP | 2025-03-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207648-004 | NPP | 2025-03-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N207648-001 | NPP | 2025-03-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N207648-002 | NPP | 2025-03-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N207648-003 | NPP | 2025-03-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N207648-004 | NPP | 2025-03-22 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207648-001 | NPP | 2025-03-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207648-002 | NPP | 2025-03-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207648-003 | NPP | 2025-03-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207648-004 | NPP | 2025-03-22 | 5c6f7cd8ea54… |
| 2019-12-13 00:20 UTC | 2019-12 | N207648-001 | NCE | 2021-07-13 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N207648-002 | NCE | 2021-07-13 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N207648-003 | NCE | 2021-07-13 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N207648-004 | NCE | 2021-07-13 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N207648-001 | NCE | 2021-07-13 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N207648-002 | NCE | 2021-07-13 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N207648-003 | NCE | 2021-07-13 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N207648-004 | NCE | 2021-07-13 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207648-001 | NCE | 2021-07-13 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207648-002 | NCE | 2021-07-13 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207648-003 | NCE | 2021-07-13 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207648-004 | NCE | 2021-07-13 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N207648-001 | NCE | 2021-07-13 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N207648-002 | NCE | 2021-07-13 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N207648-003 | NCE | 2021-07-13 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N207648-004 | NCE | 2021-07-13 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N207648-001 | NCE | 2021-07-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N207648-002 | NCE | 2021-07-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N207648-003 | NCE | 2021-07-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N207648-004 | NCE | 2021-07-13 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N207648-001 | NCE | 2021-07-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N207648-002 | NCE | 2021-07-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N207648-003 | NCE | 2021-07-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N207648-004 | NCE | 2021-07-13 | c0c555d07b60… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Smoflipid | SMOFLIPID | Fresenius Kabi USA, LLC | e0e9d917-ff6f-488e-a6a8-0ad59dd17d80 | 2025-08-15 | Warnings, Adverse reactions | 207648 NDA207648 63323-820 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-820 | Smoflipid | Smoflipid | Fresenius Kabi USA, LLC | NDA | Current |