Drugs@FDA: FDA Approved Drug Products

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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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Letter (PDF)

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 Letter (PDF)

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 Label (PDF)
Letter (PDF)
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 Letter (PDF)
Review (PDF)

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 Review (PDF)

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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