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
ADDYI از شرکت SPROUT PHARMS
New Drug Application (NDA): 022526
Company: SPROUT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADDYI | FLIBANSERIN | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/18/2015 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-9 | REMS – MODIFIED – D-N-A |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s009ltr.pdf |
||
| 10/09/2019 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s008ltr.pdf |
||
| 04/02/2019 | SUPPL-7 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s007ltr.pdf |
|
| 04/11/2019 | SUPPL-6 |
SLC Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/SLC/2019/022526_SLC OrderLtr.pdf |
||
| 06/16/2017 | SUPPL-4 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022526Orig1s004ltr.pdf |
|
| 04/08/2016 | SUPPL-2 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022526Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-9 |
REMS – MODIFIED – D-N-A |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf | |
| 10/09/2019 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf | |
| 08/18/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf |
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