Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021336
Company: SOMERSET
Company: SOMERSET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMSAM | SELEGILINE | 6MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | Yes |
EMSAM | SELEGILINE | 9MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
EMSAM | SELEGILINE | 12MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/27/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/14/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021336Orig1s014ltr.pdf | |
10/16/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/2015 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021336Orig1s011ltr.pdf | |
09/10/2014 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf |
09/10/2014 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf | |
07/30/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021336s002ltr.pdf | |
02/13/2008 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021336s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/14/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf | |
03/27/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf | |
03/27/2015 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf | |
03/27/2015 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf | |
09/10/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf | |
07/30/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf | |
02/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf |