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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/02/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 05/11/2021 | SUPPL-72 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019627Orig1s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019627Orig1s072ltr.pdf | |
| 08/31/2022 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019627s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019627Orig1s069ltr.pdf | |
| 04/27/2017 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019627Orig1s066ltr.pdf | |
| 04/17/2015 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2014 | SUPPL-62 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf | |
| 07/09/2013 | SUPPL-60 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019627Orig1s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019627Orig1s060.pdf | |
| 05/05/2014 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2008 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019627s046ltr.pdf | |
| 02/08/2007 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019627s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019627_S045_DIPRIVAN.pdf | |
| 09/03/2002 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2000 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2001 | SUPPL-35 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019627_S035_DiprivanTOC.cfm | |
| 04/29/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1999 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/11/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1996 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019627_S027_Diprivan_APPROVAL_PACKAGE.pdf |
| 07/31/1995 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/21/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/06/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1995 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/26/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/26/1993 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1993 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/09/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-2 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019627_S002_Diprivan.pdf |
| 01/18/1991 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| 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 |
DIPRIVAN
INJECTABLE;INJECTION; 10MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 019627 | FRESENIUS KABI USA |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 206408 | AVET LIFESCIENCES |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 205067 | DR REDDYS |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 074848 | HIKMA |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 077908 | HOSPIRA |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 205576 | INNOPHARMA |
| PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 075102 | SAGENT PHARMS INC |