Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021708
Company: SOMERSET
Company: SOMERSET
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMSAM | SELEGILINE | 6MG | SYSTEM; TRANSDERMAL | Prescription | None | No | No |
| EMSAM | SELEGILINE | 9MG | SYSTEM; TRANSDERMAL | Prescription | None | No | No |
| EMSAM | SELEGILINE | 12MG | SYSTEM; TRANSDERMAL | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf | |
| 02/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf |