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
ACEON از شرکت SYMPLMED PHARMS LLC
New Drug Application (NDA): 020184
Company: SYMPLMED PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEON | PERINDOPRIL ERBUMINE | 2MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| ACEON | PERINDOPRIL ERBUMINE | 4MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| ACEON | PERINDOPRIL ERBUMINE | 8MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1993 | 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 |
|---|---|---|---|---|---|
| 09/29/2017 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020184s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020184s023ltr.pdf |
||
| 03/30/2015 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020184s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020184Orig1s022ltr.pdf |
||
| 02/26/2013 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020184s020lblupdated.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020184Orig1s020ltr_replace.pdf |
||
| 04/11/2012 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020184s019ltr.pdf |
||
| 08/23/2011 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020184s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020184s017ltr.pdf |
||
| 12/10/2010 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020184s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020184s015ltr.pdf |
||
| 09/03/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf |
|
| 09/03/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf |
|
| 08/23/2005 | SUPPL-11 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020184s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020184s011ltr.pdf |
||
| 10/29/2003 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20184slr009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020184_S009_ACEON.pdf |
|
| 11/20/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020184ap.pdf |
|
| 11/14/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1994 | 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 |
|---|---|---|---|---|---|
| 09/29/2017 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020184s023lbl.pdf | |
| 03/30/2015 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020184s022lbl.pdf | |
| 02/26/2013 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020184s020lblupdated.pdf | |
| 04/11/2012 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf | |
| 08/23/2011 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020184s017lbl.pdf | |
| 12/10/2010 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020184s015lbl.pdf | |
| 08/23/2005 | SUPPL-11 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020184s011lbl.pdf |
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