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 |
| 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 |