Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204508
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINOLIPID 20% | OLIVE OIL; SOYBEAN OIL | 16%(160GM/1000ML);4% (40GM/1000ML) | EMULSION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/03/2013 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/24/2024 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204508s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204508Orig1s022ltr.pdf | |
05/17/2023 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204508Orig1s019,s021ltr.pdf | |
05/17/2023 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204508Orig1s019,s021ltr.pdf | |
04/13/2021 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020678Orig1s042, 020734Orig1s037, 204508Orig1s015ltr.pdf | |
01/09/2017 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/20/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf | |
02/08/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/06/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/24/2024 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204508s022lbl.pdf | |
05/17/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf | |
05/17/2023 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf | |
05/17/2023 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204508s019s021lbl.pdf | |
04/13/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204508s015lbl.pdf | |
07/20/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf | |
10/03/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf |