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
BELSOMRA از شرکت MERCK SHARP DOHME
New Drug Application (NDA): 204569
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BELSOMRA | SUVOREXANT | 5MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| BELSOMRA | SUVOREXANT | 10MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| BELSOMRA | SUVOREXANT | 15MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| BELSOMRA | SUVOREXANT | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/13/2014 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/25/2021 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204569Orig1s008ltr.pdf |
||
| 03/18/2020 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s007ltr.pdf |
||
| 01/29/2020 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s006ltr.pdf |
||
| 07/12/2018 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204569Orig1s005ltr.pdf |
||
| 05/27/2016 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf |
|
| 05/03/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/25/2021 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf | |
| 03/18/2020 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf | |
| 01/29/2020 | SUPPL-6 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf | |
| 07/12/2018 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf | |
| 11/07/2014 | SUPPL-1 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf | |
| 08/13/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf |
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