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
BOSULIF از شرکت PF PRISM CV
New Drug Application (NDA): 203341
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOSULIF | BOSUTINIB MONOHYDRATE | EQ 100MG BASE | TABLET;ORAL | Prescription |
None |
Yes | Yes |
| BOSULIF | BOSUTINIB MONOHYDRATE | EQ 500MG BASE | TABLET;ORAL | Prescription |
None |
Yes | No |
| BOSULIF | BOSUTINIB MONOHYDRATE | EQ 400MG BASE | TABLET;ORAL | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 09/04/2012 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-20 | Efficacy-Accelerated Approval |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203341Orig1s020ltr.pdf |
||
| 06/17/2020 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203341s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203341Orig1s018ltr.pdf |
||
| 10/09/2019 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s017ltr.pdf |
||
| 08/14/2019 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203341Orig1s016ltr.pdf |
||
| 10/18/2018 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s015ltr.pdf |
||
| 05/01/2018 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203341Orig1s013ltr.pdf |
|
| 12/19/2017 | SUPPL-9 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s009ltr.pdf |
||
| 04/13/2017 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf |
||
| 04/13/2017 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203341Orig1s007s008ltr.pdf |
||
| 11/17/2016 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s006ltr.pdf |
||
| 04/04/2016 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf |
||
| 10/08/2015 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf |
||
| 11/25/2014 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf |
||
| 09/30/2013 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-20 |
Efficacy-Accelerated Approval |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s020lbl.pdf | |
| 06/17/2020 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203341s018lbl.pdf | |
| 10/09/2019 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s017lbl.pdf | |
| 08/14/2019 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203341s016lbl.pdf | |
| 10/18/2018 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf | |
| 12/19/2017 | SUPPL-9 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203341s009lbl.pdf | |
| 04/13/2017 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf | |
| 04/13/2017 | SUPPL-7 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20334s007s008lbl.pdf | |
| 11/17/2016 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s006lbl.pdf | |
| 04/04/2016 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf | |
| 09/22/2015 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf | |
| 11/25/2014 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf | |
| 09/30/2013 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf | |
| 09/04/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf |
نظرات کاربران