Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016619
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUBLIMAZE PRESERVATIVE FREE | FENTANYL 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 |
|---|---|---|---|---|---|---|---|
| 02/19/1968 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016619s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016619Orig1s054ltr.pdf | |
| 04/12/2022 | SUPPL-52 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016619Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016619Orig1s052ltr.pdf | |
| 08/08/2022 | SUPPL-45 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/005939Orig1s012;011525Orig1s031;012015Orig1s036;016619Orig1s045;019353Orig1s024;208609Orig1s006correctedltr.pdf |
| 10/07/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016619s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016619Orig1s043ltr.pdf | |
| 01/24/2019 | SUPPL-39 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016619Orig1s039ltr.pdf |
| 12/16/2016 | SUPPL-38 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016619Orig1s038ltr.pdf | |
| 05/18/2016 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2013 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016619Orig1s034ltr.pdf | |
| 10/17/2003 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16619slr032ltr.pdf |
| 04/26/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-27 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018401Orig1s027ltr.pdf |
| 12/23/1993 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1992 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1990 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/05/1986 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/05/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/07/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/24/1981 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1976 | SUPPL-4 | Labeling |
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-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016619s054lbl.pdf | |
| 04/12/2022 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016619Orig1s052lbl.pdf | |
| 04/12/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016619Orig1s052lbl.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016619s043lbl.pdf | |
| 12/16/2016 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf | |
| 12/16/2016 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf | |
| 07/03/2013 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf |
SUBLIMAZE 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 |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212086 | FRESENIUS KABI USA |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019101 | HIKMA |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 019115 | HOSPIRA |
| FENTANYL CITRATE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210762 | FRESENIUS KABI USA |
| FENTANYL CITRATE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072786 | HOSPIRA |
| SUBLIMAZE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016619 | RISING |