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 از شرکت UPJOHN
New Drug Application (NDA): 019668
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDURA | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
| CARDURA | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CARDURA | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CARDURA | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/1990 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/23/2021 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019668Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019668Orig1s032ltr.pdf |
||
| 06/09/2016 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019668Orig1s028ltr.pdf |
||
| 07/28/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2013 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019668Orig1s026ltr.pdf |
||
| 01/14/2010 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019668s022ltr.pdf |
||
| 07/10/2009 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf |
||
| 02/28/2006 | SUPPL-17 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019668s017ltr.pdf |
|
| 09/13/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19668s15ltr.pdf |
|
| 10/10/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/13/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19668slr012ltr.pdf |
|
| 07/21/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/18/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1991 | 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 |
|---|---|---|---|---|---|
| 06/23/2021 | SUPPL-32 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019668Orig1s032lbl.pdf | |
| 06/23/2021 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019668Orig1s032lbl.pdf | |
| 06/09/2016 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf | |
| 11/06/2013 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf | |
| 01/14/2010 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf | |
| 07/10/2009 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf |
CARDURA
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDURA | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | UPJOHN |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075750 | PLIVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDURA | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | UPJOHN |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075750 | PLIVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 4MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDURA | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | UPJOHN |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075750 | PLIVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 8MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDURA | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | UPJOHN |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075750 | PLIVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
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