Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020297
Company: WAYLIS THERAP

• Patient Information Sheet

Products on NDA 20297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COREG	CARVEDILOL	25MG	TABLET;ORAL	Prescription	AB	Yes	No
COREG	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	AB	Yes	Yes
COREG	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	AB	Yes	No
COREG	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 020297

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2023	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020297Orig1s039correctedlbl.pdf
09/14/2017	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf
10/02/2015	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf
07/06/2011	SUPPL-36	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf
01/25/2011	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf
01/06/2011	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
01/06/2011	SUPPL-34	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
06/23/2009	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf
12/19/2008	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf
07/22/2008	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf
02/23/2007	SUPPL-22	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf
08/28/2006	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf
04/29/2005	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf
11/01/2001	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf