اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLINOLIPID 20% از شرکت BAXTER HLTHCARE CORP
New Drug Application (NDA): 204508
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/13/2021 | SUPPL-15 | Labeling-Package Insert |
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 |
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 |
|---|---|---|---|---|---|
| 04/13/2021 | 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 |
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