Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019531
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUTRILIPID 10% | SOYBEAN OIL | 10% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| NUTRILIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/24/2025 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019531s017s018lbl.pdf | |
| 07/24/2025 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019531s017s018lbl.pdf | |
| 05/17/2023 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019531s013s016lbl.pdf | |
| 07/14/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019531s010lbl.pdf | |
| 08/12/2014 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019531s002lbl.pdf |