Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019050
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUFENTA PRESERVATIVE FREE | SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/04/1984 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019050s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019050Orig1s043ltr.pdf | |
| 10/07/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019050s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019050Orig1s037ltr.pdf | |
| 12/16/2016 | SUPPL-34 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019050Orig1s034ltr.pdf | |
| 03/20/2014 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019050Orig1s032ltr.pdf | |
| 06/04/2007 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019050s031ltr.pdf | |
| 05/25/1999 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/21/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/12/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1994 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/1994 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1993 | SUPPL-17 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 10/05/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/20/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/21/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1984 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019050s043lbl.pdf | |
| 10/07/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019050s037lbl.pdf | |
| 12/16/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf | |
| 12/16/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf | |
| 03/20/2014 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf | |
| 03/20/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf | |
| 06/04/2007 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf |
SUFENTA PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SUFENTA PRESERVATIVE FREE | SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019050 | RISING |
| SUFENTANIL CITRATE | SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074413 | HIKMA |
| SUFENTANIL CITRATE | SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074534 | HOSPIRA |