Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021319
Company: WAYLIS THERAP

• Summary Review

• Other Important Information from FDA

Products on NDA 21319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVODART	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 021319

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2020	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021319s032lbl.pdf
04/30/2013	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
04/30/2013	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf
06/27/2012	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf
06/09/2011	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
06/09/2011	SUPPL-23	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf
09/09/2010	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf
06/15/2010	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf
06/19/2008	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf
03/31/2008	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf
09/14/2004	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf
08/05/2004	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf
10/09/2002	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf
11/20/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf