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
CORLANOR از شرکت AMGEN INC
New Drug Application (NDA): 206143
Company: AMGEN INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CORLANOR | IVABRADINE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription |
None |
Yes | No |
CORLANOR | IVABRADINE HYDROCHLORIDE | EQ 7.5MG BASE | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/15/2015 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/04/2021 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206143Orig1s008;209964Orig1s002ltr.pdf |
||
05/13/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206143Orig1s007ltr.pdf |
||
01/10/2017 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206143Orig1s002ltr.pdf |
||
05/05/2016 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/04/2021 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lbl.pdf | |
08/04/2021 | SUPPL-8 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lbl.pdf | |
05/13/2019 | SUPPL-7 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf | |
05/13/2019 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf | |
01/10/2017 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf | |
04/15/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf |
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