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
ALIQOPA از شرکت BAYER HEALTHCARE
New Drug Application (NDA): 209936
Company: BAYER HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALIQOPA | COPANLISIB DIHYDROCHLORIDE | 60MG/VIAL | POWDER;INTRAVENOUS | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/14/2017 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/12/2020 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209936s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209936Orig1s004ltr.pdf |
||
| 10/28/2019 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s003ltr.pdf |
||
| 05/24/2019 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2020 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209936s004lbl.pdf | |
| 10/28/2019 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s003lbl.pdf | |
| 05/24/2019 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s002lbl.pdf | |
| 09/14/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf |
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