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 GLAXOSMITHKLINE LLC
Biologic License Application (BLA): 761043
Company: GLAXOSMITHKLINE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENLYSTA | BELIMUMAB | 200MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2017 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761043lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-13 | 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 |
||
| 01/17/2020 | SUPPL-8 | 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 |
||
| 04/26/2019 | SUPPL-7 | 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 |
||
| 09/13/2019 | SUPPL-5 | 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 |
||
| 06/22/2018 | SUPPL-2 | 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-13 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf | |
| 01/17/2020 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf | |
| 09/13/2019 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf | |
| 04/26/2019 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf | |
| 06/22/2018 | SUPPL-2 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
| 06/22/2018 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
| 06/22/2018 | SUPPL-2 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
| 07/20/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761043lbl.pdf |
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