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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020184
Company: SYMPLMED PHARMS LLC

Other Important Information from FDA

Products on NDA 020184

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020184

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.

Labels for NDA 020184

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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