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
BENLYSTA از شرکت HUMAN GENOME SCIENCES INC.
Biologic License Application (BLA): 125370
Company: HUMAN GENOME SCIENCES INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENLYSTA | BELIMUMAB | 120MG | INJECTABLE; INJECTION | Prescription |
None |
No | No |
| BENLYSTA | BELIMUMAB | 400MG | INJECTABLE; INJECTION | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 03/09/2011 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-73 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s073_761043Orig1s013ltr.pdf |
||
| 09/24/2020 | SUPPL-71 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s071ltr.pdf |
||
| 01/17/2020 | SUPPL-68 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s068, 761043Orig1s008ltr.pdf |
||
| 09/13/2019 | SUPPL-67 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s067, 761043Orig1s005ltr.pdf |
||
| 04/26/2019 | SUPPL-64 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s064; 761043Orig1s007_REPLACEMENTltr.pdf |
||
| 06/22/2018 | SUPPL-62 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf |
||
| 01/18/2017 | SUPPL-57 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125370Orig1s057ltr.pdf |
||
| 12/02/2016 | SUPPL-55 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125370Orig1s055ltr.pdf |
||
| 04/03/2014 | SUPPL-53 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125370Orig1s053ltr.pdf |
||
| 12/13/2013 | SUPPL-47 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125370Orig1s047ltr.pdf |
||
| 03/30/2012 | SUPPL-16 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125370s016ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-73 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf | |
| 09/24/2020 | SUPPL-71 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s071lbl.pdf | |
| 01/17/2020 | SUPPL-68 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf | |
| 09/13/2019 | SUPPL-67 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf | |
| 04/26/2019 | SUPPL-64 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf | |
| 06/22/2018 | SUPPL-62 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
| 01/18/2017 | SUPPL-57 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf | |
| 01/18/2017 | SUPPL-57 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf | |
| 12/02/2016 | SUPPL-55 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf | |
| 04/03/2014 | SUPPL-53 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf | |
| 12/13/2013 | SUPPL-47 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf | |
| 03/30/2012 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf | |
| 03/09/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf |
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