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
ABSTRAL از شرکت SENTYNL THERAPS INC
New Drug Application (NDA): 022510
Company: SENTYNL THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABSTRAL | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
| ABSTRAL | FENTANYL CITRATE | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
| ABSTRAL | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
| ABSTRAL | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
| ABSTRAL | FENTANYL CITRATE | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
| ABSTRAL | FENTANYL CITRATE | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;SUBLINGUAL | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/07/2011 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022510Orig1s018ltr.pdf |
||
| 09/07/2017 | SUPPL-17 | REMS-Proposal |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022510Orig1s017ltr.pdf |
|
| 12/16/2016 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022510Orig1s015ltr.pdf |
||
| 12/24/2014 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf |
|
| 11/04/2014 | SUPPL-13 | REMS-Modified, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf |
||
| 10/02/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2013 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf |
||
| 11/07/2013 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf |
|
| 06/05/2012 | SUPPL-5 | REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf |
||
| 12/28/2011 | SUPPL-3 | REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf | |
| 10/07/2019 | SUPPL-18 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf | |
| 12/16/2016 | SUPPL-15 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf | |
| 12/16/2016 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf | |
| 11/04/2014 | SUPPL-13 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf | |
| 11/04/2014 | SUPPL-13 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf | |
| 07/26/2013 | SUPPL-10 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf | |
| 07/26/2013 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf | |
| 06/05/2012 | SUPPL-5 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf | |
| 12/28/2011 | SUPPL-3 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf | |
| 01/07/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf |
نظرات کاربران