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
ADEMPAS از شرکت BAYER HLTHCARE
New Drug Application (NDA): 204819
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADEMPAS | RIOCIGUAT | 0.5MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ADEMPAS | RIOCIGUAT | 1MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ADEMPAS | RIOCIGUAT | 1.5MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ADEMPAS | RIOCIGUAT | 2MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ADEMPAS | RIOCIGUAT | 2.5MG | TABLET;ORAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 10/08/2013 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/2020 | SUPPL-14 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s014ltr.pdf |
|
| 11/30/2020 | SUPPL-13 | REMS – MODIFIED – D-N-A, REMS – MODIFIED – BIFURCATED |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s013ltr.pdf |
|
| 01/11/2018 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819Orig1s011ltr.pdf |
||
| 12/06/2018 | SUPPL-9 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819s009ltr.pdf |
|
| 02/23/2017 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s008ltr.pdf |
||
| 10/04/2016 | SUPPL-7 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf |
|
| 01/17/2017 | SUPPL-6 | REMS – MODIFIED – D-N-A |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s006ltr.pdf |
||
| 12/04/2015 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf |
|
| 02/23/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2014 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf |
||
| 06/11/2014 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/11/2018 | SUPPL-11 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf | |
| 02/23/2017 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf | |
| 01/17/2017 | SUPPL-6 |
REMS – MODIFIED – D-N-A |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf | |
| 05/06/2014 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf | |
| 10/08/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf |
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