اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALFENTA از شرکت AKORN
New Drug Application (NDA): 019353
Company: AKORN
| 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 |
|
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 |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-23 | Labeling-Package Insert |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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 | AKORN |
| ALFENTANIL | ALFENTANIL HYDROCHLORIDE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075221 | HOSPIRA |
نظرات کاربران