Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018449
Company: FRESENIUS
Company: FRESENIUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INTRALIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2023 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017643Orig1s083;018449Orig1s050,s051 019942Orig1s021;020248Orig1s027,s028ltr.pdf | |
| 05/17/2023 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017643Orig1s083;018449Orig1s050,s051 019942Orig1s021;020248Orig1s027,s028ltr.pdf | |
| 05/03/2022 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018449s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017643Orig1s082, 018449Orig1s049, 019942Orig1s020, 020248Orig1s026ltr.pdf | |
| 07/25/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf | |
| 12/01/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018449s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf | |
| 04/24/2007 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf | |
| 04/16/2004 | SUPPL-37 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf |
| 08/22/2001 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/2000 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/17/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/20/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1985 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/27/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1983 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/06/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/02/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1981 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/06/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/03/1981 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/15/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/17/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf | |
| 05/17/2023 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf | |
| 05/03/2022 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018449s049lbl.pdf | |
| 07/25/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017643s078,018449s045,019942s016,020248s022lbl.pdf | |
| 12/01/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018449s043lbl.pdf | |
| 04/24/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf |
INTRALIPID 20%
INJECTABLE;INJECTION; 20%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INTRALIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018449 | FRESENIUS |
| INTRALIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 020248 | FRESENIUS |
| NUTRILIPID 20% | SOYBEAN OIL | 20% | INJECTABLE;INJECTION | Prescription | Yes | AP | 019531 | B BRAUN |