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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020884
Company: BOEHRINGER INGELHEIM

Products on NDA 020884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AGGRENOX	ASPIRIN; DIPYRIDAMOLE	25MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020884

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/1999	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_Aggrenox.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2021	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020884s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020884Orig1s040ltr.pdf
12/11/2019	SUPPL-39	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020884s039lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020884Orig1s039ltr.pdf
11/09/2018	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020884s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020884Orig1s037ltr.pdf
11/09/2015	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020884Orig1s035ltr.pdf
05/30/2014	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
05/29/2013	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
09/07/2012	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020884Orig1s030ltr.pdf
10/01/2009	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020884s018ltr.pdf
11/28/2006	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020884s014ltr.pdf
03/26/2007	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020884s012ltr.pdf
01/28/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20884slr007ltr.pdf
06/20/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/21/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/23/2001	SUPPL-3	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20884S3ltr.pdf
10/17/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/10/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf

Labels for NDA 020884

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2021	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020884s040lbl.pdf
12/11/2019	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020884s039lbledt.pdf
11/09/2018	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020884s037lbl.pdf
11/09/2015	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf
09/07/2012	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf
10/01/2009	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf
03/26/2007	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf
11/28/2006	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf
08/10/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf
11/22/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf

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