Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019353
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALFENTA | ALFENTANIL HYDROCHLORIDE | EQ 0.5MG 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019353Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019353s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019353Orig1s029ltr.pdf | |
| 08/08/2022 | SUPPL-24 | 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-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019353s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019353Orig1s023ltr.pdf | |
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019353Orig1s021ltr.pdf | |
| 07/24/2015 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019353Orig1s019ltr.pdf | |
| 05/25/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/20/1998 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1993 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/10/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1990 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1988 | SUPPL-1 | 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-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019353s029lbl.pdf | |
| 10/07/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019353s023lbl.pdf | |
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf | |
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf | |
| 07/24/2015 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf | |
| 07/24/2015 | SUPPL-19 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf |
ALFENTA
INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALFENTA | ALFENTANIL HYDROCHLORIDE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019353 | RISING |
| ALFENTANIL | ALFENTANIL HYDROCHLORIDE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075221 | HOSPIRA |