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
CORDARONE از شرکت WYETH PHARMS
New Drug Application (NDA): 018972
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORDARONE | AMIODARONE HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 12/24/1985 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-972_Cardarone.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/17/2018 | SUPPL-54 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018972Orig1s054ltr.pdf |
||
| 04/07/2017 | SUPPL-53 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018972Orig1s053ltr.pdf |
||
| 11/22/2016 | SUPPL-52 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s052ltr.pdf |
||
| 04/22/2016 | SUPPL-51 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf |
||
| 12/22/2014 | SUPPL-50 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s050ltr.pdf |
||
| 01/17/2014 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2014 | SUPPL-48 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s048ltr.pdf |
||
| 03/27/2015 | SUPPL-47 | Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018972Orig1s047ltr.pdf |
||
| 11/20/2012 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/2011 | SUPPL-44 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018972s044ltr.pdf |
||
| 12/13/2010 | SUPPL-42 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018972s042ltr.pdf |
||
| 11/19/2009 | SUPPL-41 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s041ltr.pdf |
||
| 09/28/2009 | SUPPL-40 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s040ltr.pdf |
|
| 04/21/2009 | SUPPL-39 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s39ltr.pdf |
||
| 04/21/2009 | SUPPL-38 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s039ltr.pdf |
||
| 10/17/2008 | SUPPL-37 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018972s037ltr.pdf |
|
| 11/13/2007 | SUPPL-36 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s036LTR.pdf |
|
| 10/02/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s035ltr.pdf |
|
| 03/30/2007 | SUPPL-34 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s034ltr.pdf |
|
| 08/28/2006 | SUPPL-33 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s033ltr.pdf |
|
| 09/21/2006 | SUPPL-32 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s032ltr.pdf |
|
| 08/23/2005 | SUPPL-31 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018972s031ltr.pdf |
|
| 12/03/2004 | SUPPL-30 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone.cfm |
||
| 11/01/2004 | SUPPL-29 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s029ltr.pdf |
|
| 09/02/2004 | SUPPL-28 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s028ltr.pdf |
|
| 05/21/2004 | SUPPL-27 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf |
|
| 05/06/2003 | SUPPL-26 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/018972s026ltr.pdf |
|
| 12/18/2002 | SUPPL-25 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18972slr025ltr.pdf |
|
| 09/20/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_18972slr023ltr.pdf |
|
| 05/21/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf |
|
| 12/18/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/08/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf |
|
| 10/08/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf |
|
| 06/15/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf |
|
| 01/05/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm |
|
| 06/15/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf |
|
| 01/05/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm |
|
| 10/18/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf |
|
| 04/14/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/09/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/28/1989 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/28/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1987 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/15/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/13/1988 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/17/2018 | SUPPL-54 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf | |
| 04/07/2017 | SUPPL-53 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf | |
| 11/22/2016 | SUPPL-52 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s052lbl.pdf | |
| 04/22/2016 | SUPPL-51 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf | |
| 03/27/2015 | SUPPL-47 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf | |
| 12/22/2014 | SUPPL-50 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf | |
| 01/22/2014 | SUPPL-48 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf | |
| 11/14/2011 | SUPPL-44 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf | |
| 12/13/2010 | SUPPL-42 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf | |
| 11/19/2009 | SUPPL-41 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf | |
| 04/21/2009 | SUPPL-39 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf | |
| 04/21/2009 | SUPPL-38 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf | |
| 12/03/2004 | SUPPL-30 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf |
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