Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019942
Company: FRESENIUS
Company: FRESENIUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INTRALIPID 30% | SOYBEAN OIL | 30% | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
12/30/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019942_ORIGINAL_APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/22/2024 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019942s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019942Orig1s022ltr.pdf | |
05/17/2023 | SUPPL-21 | 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-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019942s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017643Orig1s082, 018449Orig1s049, 019942Orig1s020, 020248Orig1s026ltr.pdf | |
07/25/2018 | SUPPL-16 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017643Orig1s078,018449Orig1s045,019942Orig1s016,020248Orig1s022Ltr.pdf |
12/01/2016 | SUPPL-14 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017643Orig1s076,018449Orig1s043,019942Orig1s014,020248Orig1s020ltr.pdf |
04/16/2004 | SUPPL-10 | 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-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/21/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/18/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/1997 | 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 |
---|---|---|---|---|---|
02/22/2024 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019942s022lbl.pdf | |
05/17/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017643s083,018449s050s051,019942s021,020248s027s028lbl.pdf | |
05/03/2022 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019942s020lbl.pdf |