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
CARVEDILOL از شرکت SUN PHARM INDS INC
Abbreviated New Drug Application (ANDA): 077346
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Discontinued |
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 |
|---|---|---|---|---|---|---|---|
| 09/05/2007 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/01/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/01/2016 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-11 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/31/2011 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/15/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/05/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf |
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