Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022460
Company: GLAXOSMITHKLINE
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
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/2010/022460s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 202975 ACTAVIS LABS FL INC
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 GLAXOSMITHKLINE

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