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Drugs@FDA: FDA-Approved Drugs

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

Summary Review

Other Important Information from FDA

Products on NDA 021319

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen_approv.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021319s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021319Orig1s032ltr.pdf
09/10/2013	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
04/30/2013	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
04/30/2013	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf
06/27/2012	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021319s027ltr.pdf
06/09/2011	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
06/09/2011	SUPPL-23	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf
09/09/2010	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s022ltr.pdf
06/15/2010	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s018ltr.pdf
03/31/2008	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319s015ltr.pdf
06/19/2008	SUPPL-14	Efficacy-New Indication	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319se1-014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-014_SUMR.pdf
12/23/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021319s009rev2.pdf
09/14/2004	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s008ltr.pdf
08/05/2004	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s007ltr.pdf
03/12/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319slr005ltr.pdf
12/31/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/09/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/09/2002	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21319se1-001ltr.pdf

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

Therapeutic Equivalents for NDA 021319

AVODART

CAPSULE;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVODART	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	Yes	AB	021319	WAYLIS THERAP
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	206373	ACELLA
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204376	ADAPTIS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	203118	AMNEAL PHARMS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	206574	ASCENT PHARMS INC
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	202660	AUROBINDO PHARMA LTD
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	090095	BARR
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	200899	CHARTWELL
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	209909	HUMANWELL PURACAP
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204262	STRIDES SOFTGELS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204373	ZYDUS LIFESCIENCES

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