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
CYRAMZA از شرکت ELI LILLY AND CO
Biologic License Application (BLA): 125477
Company: ELI LILLY AND CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYRAMZA | RAMUCIRUMAB | 100MG/10ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CYRAMZA | RAMUCIRUMAB | 500MG/50ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/2014 | ORIG-1 | Approval |
N/A; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2021 | SUPPL-39 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125477s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125477Orig1s039ltr.pdf |
||
| 07/06/2020 | SUPPL-37 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s037ltr.pdf |
||
| 02/20/2020 | SUPPL-36 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s036ltr.pdf |
||
| 11/05/2019 | SUPPL-35 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s035ltr.pdf |
|
| 05/29/2020 | SUPPL-34 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125477Orig1s034ltr.pdf |
||
| 07/31/2019 | SUPPL-33 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s033ltr.pdf |
||
| 11/26/2018 | SUPPL-31 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s031ltr.pdf |
|
| 08/14/2018 | SUPPL-30 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125477Orig1s030REPLACEMENT LETTER.pdf |
||
| 05/10/2019 | SUPPL-29 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125477Orig1s029ltr.pdf |
|
| 04/24/2015 | SUPPL-11 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125477Orig1s011ltr.pdf |
||
| 12/12/2014 | SUPPL-7 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s007ltr.pdf |
||
| 11/05/2014 | SUPPL-2 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2021 | SUPPL-39 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125477s039lbl.pdf | |
| 07/06/2020 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s037lbl.pdf | |
| 05/29/2020 | SUPPL-34 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s034lbl.pdf | |
| 02/20/2020 | SUPPL-36 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s036lbl.pdf | |
| 07/31/2019 | SUPPL-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125477s033lbl.pdf | |
| 08/14/2018 | SUPPL-30 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf | |
| 04/24/2015 | SUPPL-11 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf | |
| 12/12/2014 | SUPPL-7 |
Efficacy |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf | |
| 11/05/2014 | SUPPL-2 |
Efficacy |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf | |
| 04/21/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf |
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