Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022460
Company: WAYLIS THERAP
Company: WAYLIS THERAP
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 |
---|---|---|---|---|---|
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 |
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 |
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 | 213300 | AUROBINDO PHARMA |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5MG;0.4MG | CAPSULE;ORAL | Prescription | No | AB | 202509 | ENDO OPERATIONS |
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 | WAYLIS THERAP |