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
CARDURA XL از شرکت UPJOHN
New Drug Application (NDA): 021269
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDURA XL | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| CARDURA XL | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/22/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/22/2021 | SUPPL-21 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021269Orig1s021ltr.pdf |
||
| 02/27/2017 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021269Orig1s018ltr.pdf |
||
| 06/08/2015 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021269Orig1s17ltr.pdf |
||
| 07/28/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2012 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2011 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021269s012ltr.pdf |
||
| 03/16/2010 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021269s011ltr.pdf |
||
| 03/24/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021269s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/22/2021 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf | |
| 06/22/2021 | SUPPL-21 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf | |
| 02/27/2017 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf | |
| 06/08/2015 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf | |
| 07/08/2011 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf | |
| 03/16/2010 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf | |
| 02/22/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf |
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