Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019627
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/31/2022 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019627s069lbl.pdf | |
| 05/11/2021 | SUPPL-72 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019627Orig1s072lbl.pdf | |
| 05/11/2021 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019627Orig1s072lbl.pdf | |
| 04/27/2017 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf | |
| 06/08/2014 | SUPPL-62 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf |
| 07/09/2013 | SUPPL-60 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf |
| 04/14/2008 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf | |
| 02/08/2007 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf | |
| 02/23/2001 | SUPPL-35 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf |