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
ACTEMRA از شرکت GENENTECH
Biologic License Application (BLA): 125472
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTEMRA | TOCILIZUMAB | 162MG/0.9ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2013 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/22/2021 | SUPPL-45 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125472Orig1s045, 125276Orig1s135ltr.pdf |
|
| 03/04/2021 | SUPPL-44 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125472Orig1s044ltr.pdf |
||
| 05/28/2020 | SUPPL-42 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125472Orig1s042,125276Orig1s129ltr.pdf |
||
| 06/11/2019 | SUPPL-40 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125276Orig1s127; 125472Orig1s040ltr.pdf |
||
| 12/20/2018 | SUPPL-38 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s038Ltr.pdf |
||
| 04/11/2019 | SUPPL-37 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125472s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125472Orig1s037ltr.pdf |
||
| 05/17/2018 | SUPPL-32 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s117,125472Orig1s032ltr.pdf |
||
| 09/12/2018 | SUPPL-31 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s031,125276Orig1s122Ltr.pdf |
||
| 03/22/2018 | SUPPL-30 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s116,125472Orig1s030ltr.pdf |
||
| 11/19/2018 | SUPPL-29 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s029,125276Orig1s118ltr.pdf |
||
| 05/11/2018 | SUPPL-28 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s115,125472Orig1s028ltr.pdf |
||
| 05/22/2017 | SUPPL-24 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125472Orig1s024ltr.pdf |
||
| 03/30/2017 | SUPPL-23 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s111,125472Orig1s023ltr.pdf |
||
| 09/23/2016 | SUPPL-18 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125472Orig1s018.pdf |
||
| 08/18/2015 | SUPPL-14 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-44 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf | |
| 05/28/2020 | SUPPL-42 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf | |
| 05/28/2020 | SUPPL-42 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf | |
| 05/28/2020 | SUPPL-42 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf | |
| 06/11/2019 | SUPPL-40 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf | |
| 04/11/2019 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125472s037lbl.pdf | |
| 12/20/2018 | SUPPL-38 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf | |
| 11/19/2018 | SUPPL-29 |
Efficacy-Manufacturing Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf | |
| 09/12/2018 | SUPPL-31 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf | |
| 05/17/2018 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf | |
| 05/11/2018 | SUPPL-28 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf | |
| 03/22/2018 | SUPPL-30 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf | |
| 05/22/2017 | SUPPL-24 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf | |
| 03/30/2017 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf | |
| 09/23/2016 | SUPPL-18 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf | |
| 10/21/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf |
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