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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022460
Company: WOODWARD

Other Important Information from FDA

Summary Review

Products on NDA 022460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JALYN	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2010	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460s000_jalyn_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022460Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022460Orig1s011ltr.pdf
06/13/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/01/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf
11/01/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf
04/25/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf
04/25/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf
04/25/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf
06/27/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022460s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022460s002ltr.pdf
06/09/2011	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022460s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022460s001ltr.pdf

Labels for NDA 022460

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022460Orig1s011lbl.pdf
11/01/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf
11/01/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022460s007s008lbl.pdf
04/25/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf
04/25/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf
04/25/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf
06/27/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022460s002lbl.pdf
06/09/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022460s001lbl.pdf
06/14/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf

Therapeutic Equivalents for NDA 022460

JALYN

CAPSULE;ORAL; 0.5MG;0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	No	AB	202509	ANCHEN PHARMS
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	No	AB	207769	ZYDUS PHARMS
JALYN	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	Yes	AB	022460	WOODWARD

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