Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 20884

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AGGRENOX	ASPIRIN; DIPYRIDAMOLE	25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

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